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).
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.
Before moving into Regulatory Affairs, Marilyn was a research analytical chemist at Cosmair Lancome, Block Drug Company (aka GSK), and Schering-Plough Research Institute (aka Merck). She switched to Regulatory Affairs CMC (chemistry, manufacturing, and controls) while at Schering-Plough and has since worked for Kyowa Hakko Kogyo (aka Kyowa Hakko Kirin), Imclone (aka Eli Lilly), Celgene (aka Bristol Myers Squibb), and BeiGene. She is an experienced Regulatory CMC development strategist with extensive experience managing Phase 1 to Phase 3 investigational small and large molecules, and plasma drugs. Marilyn comes to TBG with 20+ years experience in pre- and post-approval Regulatory Affairs CMC. She recently served as Director Regulatory Affairs CMC - Biologics Early Development at BeiGene.
Regulatory CMC development strategy and author for INDs, IMPDs, CTAs. Drug lifecycle management. Comparability protocols (commercial)/comparability amendments (development) products.
FDA formal meetings/EMA scientific advice meetings.
Reading and hiking through the Pocono Mountains, PA and learning new crafts. When at home, she spends her time with her two cats.
The mountains and waterfalls of Belize and the Western Antilles.
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.
Dr. Miranda is a leader in the field of Medical Device development with extensive domestic and international experience in medical affairs, clinical affairs, and marketing. He has created and managed processes for post market clinical trials, investigator-initiated studies (IIS) and health economics and reimbursement. Dr. Miranda champions Evidence Based Medicine (EBM) and drives Physician and voice of the customer input in Product Development for IVD and Medical Devices. He has implemented Global Clinical Trial Management, and KOL Management and Development in the fields of Osteoporosis, Cardiac Electrophysiology (EP), Ophthalmology and Diabetes. He is currently a consultant in medical affairs and compliance with ConvaTec. Recently Dr. Miranda served as Chief Medical Officer for 3M where he led efforts in Health Care Compliance and the integration of Medical/Clinical inputs into the product development process. His expertise extended to an internal consulting role in Value Base Care, Market Access & Evidence, KOL utilization processes, and Scientific Affairs and Education among other functions. Prior to joining 3M, he served as the Chief Medical Officer-Head Health (Neurology) for GE Healthcare and led the Head Health Initiative between GE and the National Football League (NFL). During his career, he has created strategies for several international markets as well as Medical Advisory Boards for the US, Europe, Middle East, Africa (EMEA) and Latin America. Dr. Miranda has been a thought leader for the Frost & Sullivan Mind X-change and Q1 Productions.
Product Development for IVD and Medical Devices, Global Clinical Trial Management, and KOL Management and Development in the fields of Osteoporosis, Cardiac Electrophysiology (EP), Ophthalmology and Diabetes.
Camaraderie, Integrity and Transparency. Considering that as a consultant my reputation and that of the Consultancy Group I join are of paramount importance.
I love dancing, traveling, movies. I do all the Latin dances: salsa, merengue, cumbia, bachata, you name it. Not professionally, just for fun.
Argentina, Prague, Europe, Australia and South Africa
Wil comes to TBG after more than 35 years of experience as a Professor of Radiology first at Washington University in Saint Louis and then at Temple University in Philadelphia. During his academic career, he worked to pioneer early musculoskeletal ultrasound and develop protocols for musculoskeletal MRI imaging. He has extensive expertise in medical imaging, particularly with respect to musculoskeletal disease. His research centered on clinical disease as well as using neural networks for automated diagnosis of mammographic lesions, a technology for which he holds a patent. He has published 100 peer-reviewed manuscripts and 2 books as well as contributed 23 chapters to several other textbooks. He has presented over 135 lectures at local, national, and international conferences. Wil earned an MBA from Washington University in Saint Louis in 2000 and he has used these skills to investigate the economics of American medical care. After leaving academics, Wil worked 5 years in a global core laboratory, serving as a Medical Director guiding imaging trials for pharma. Here he used his experience in imaging to recommend imaging protocols and subsequently guide them to fruition.
Medical imaging includes radiography, ultrasound, CT, and MRI. Extensive knowledge of imaging musculoskeletal neoplasms, arthropathies - degenerative and inflammatory, trauma, bone densitometry, and genetic disorders. Working with biopharma for successful completion of imaging trials.
Focused, expert concierge-style consulting with a broad array of biomedical expertise, based on transparency, clarity, and honesty.
Skiing, cycling, and hiking. Investing and mathematics. French and French culture.
Wil has traveled extensively in both eastern and western Europe, particularly France. He's also visited India, Doha, Australia, New Zealand, Singapore, Mexico, and Canada. Still many places to go.
Yolanda has a PhD in Biochemistry and Molecular Biology (University of Oviedo, Spain). Her career spans academia (Washington University, St. Louis, MO; Wake Forest University, Winston-Salem, NC), pharmaceutical industry (GSK), and consulting (biotech). While at GSK she was responsible for a Discovery Performance Unit, a multidisciplinary (chemistry, biology, DMPK) and integrated group of scientists focused on identifying and progressing to the clinic novel targets for COPD and other chronic respiratory diseases. In this role, she was a key member of the Respiratory Therapy Area Executive Team, which was responsible for overseeing the progression of the respiratory portfolio (from novel targets to marketed products) in collaboration with the commercial team. Yolanda is currently a scientific advisor board member for BioSymetrics (a phenomics-driven drug discovery aimed to improve clinical translation and advance precision medicine) and RAGE Biotech (a biotech company developing novel therapeutics targeting the Receptor for Advanced Glycation Products for difficult-to-treat inflammatory diseases). Yolanda has extensive experience in implementation of collaborations and business initiatives and embedding new technologies in drug discovery.
Early drug discovery, spanning novel target/pathway identification and validation, lead optimization, candidate selection, IND-enabling studies, human biology translational studies, biomarker strategies, and early clinical studies. Track record of delivering innovative approaches enabling the discovery and progression of novel clinical candidates for a number of indications.
A sense of community and the drive to help our clients advance new medicines and clinical paradigms to serve patients.
Sailing, playing golf and reading.
London (for the perfect mix of work and play), the American West (for incredible mountains, rivers, and deserts), South Texas in winter (for bird watching), the Chesapeake Bay (for all things sailing and cruising).
Andy is a physician, scientist, entrepreneur, executive, and pharmaceutical development specialist who has founded and led multiple biotechnology companies, including Inotek Pharmaceuticals Corporation, Radikal Therapeutics, Salzman Group, Chilmark Laboratories, and Orphan Technologies, where he oversaw the entire spectrum of drug development activities, including discovery chemistry, pharmacology, and preclinical activities, manufacturing, clinical Phase I-II, as well as the US and international regulatory strategies. Following training in pediatrics, he has undertaken research and clinical fellowships in Pediatric Infectious Disease, Immunology, Parasitology, Neonatology, and Pediatric Critical Care. Andy founded and led the Division of Critical Care Medicine at Cincinnati Children’s Hospital Medical Center. He is a co-author on 50 compositions of matter chemistry patents and 200 peer-reviewed scientific publications. His research has focused on free radical biochemistry, inflammation, cannabinoid chemistry, pulmonary vascular biology, oxidant stress, shock pathophysiology, and mucosal barrier dysfunction. He has received 125 NIH, DARPA, ONR, and BARDA grants and contracts. He is the inventor of the first-in-class therapeutics that have been licensed to Genentech (INO-1001, first PARP inhibitor for treatment of cancer and myocardial infarction), formed the basis for a NASDAQ IPO (Trabadenoson, first adenosine 1 receptor agonist for glaucoma), and sold to Retrophin (OT-58, first pegylated recombinant cystathionine beta-synthase, for treatment of homocystinuria). He has raised $125 million in venture capital and institutional funds and $125 million in federal funding.
Drug development and strategic planning, medicinal chemistry, pharmacology, and toxicology, basic research, due diligence, orphan drugs, and critical care.
The Bracken Group is different because it is constructed around the concept of a single dedicated team of highly experienced drug development professionals who work together daily to ensure superior bespoke service to every client.
Downhill skiing, trans-oceanic sailing, hiking.
Cradle Mountain in Tasmania for hiking, Zermatt for skiing, the British Virgin Islands for sailing.
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!”)
Nurcan has a master's degree in Business Administration from Carlson School of Management at University of Minnesota. She started her career at Merck & Co. and has done product marketing and sales for osteoporosis, vaccines and ophthalmology business units. She was responsible for corporate account management at International Osteoporosis Foundation in Switzerland before joining TBG. Nurcan brings vast knowledge of managing global teams with diverse set of people and loves to be part of the life sciences community. Nurcan currently lives in Minnesota with her husband and two kids.
Product Sales & Marketing, Strategic Partnership and Business Development
I like the boutique feel of being surrounded by highly accomplished team of experts. The collaborative culture that favors transparency and highlight integrity as its core value ensures not only professional but also personal growth.
Playing tennis, exploring art and food cultures of the world, baking sourdough bread and cooking.
Japan for everything it offers, Turkey for its gorgeous coastline, delicious food and great friends & family, French Alps for wonderful skiing and fun friends.
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, and hiking.
Houston, TX.
Jen has 10 years of experience in digital innovation and B2B marketing at 3 top-ten pharmaceutical companies and several life sciences healthcare technology vendors and marketing agencies supporting Fortune 500 and emerging brands. Within pharma, she has expertise leveraging leading-edge data science analytics and human-centered design methods to assess clinical trial feasibility, drive study design optimization, and improve the patient journey (from recruitment through engagement). Has worked with cross-functional clinical study teams, CROs, strategic partners, and medical affairs teams to ensure an unparalleled patient experience and achieve program adoption. Additionally, she has built the product marketing strategy, digital assets, digital marketing campaigns to support new product launches and re-branding for several life sciences technology products.
Her experience gives her dual expertise in digital innovation and b2b technology marketing that she has leveraged across various full-time and consulting roles.
Digital Health · Brand-Side Experience · Data Analytics · Digital Advertising · Sales Toolkit Development · Engagement Patterns & Archetypes · Partner/Channel Programs & Marketing · Go-to-Market Strategy · Product Re-branding · Product Launch · Pharmaceuticals · Engagement Patterns & Archetypes · Clinical Trial Recruitment · Clinical Trial Feasibility
A globally distributed team with incredibly deep domain expertise and a culture of integrity, transparency, and doing the right thing.
Acting, Yoga (I teach yoga at a Cat Cafe in Manhattan), and exploring new places
St. Barts but really anywhere with a beach!
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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.
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12 Penns Trail, Newtown, PA 18940
+1 215 648 1208
© 2024 the bracken group - Privacy Policy
