EFFECTIVELY TRANSFER YOUR TECHNOLOGIES TO SUCCESSFUL COMMERCIALIZATION
Gain Actionable Assessments of the Regulatory and Clinical Landscape
TECH TRANSFER ADVISORY SERVICE
Based on popular demand and increasing requests from major universities across the United States, CRS offers Tech Transfer Advisory Services led by Senior Director of Clinical and Regulatory Affairs, Julie Cramer, PhD.
Universities are a rich source of innovative technologies for the life science ecosystem. However, not all universities are equipped to effectively transfer these technologies into the commercial realm. Even those that are equipped often need support addressing potential investor questions related to pathway to market, cost, timeline, and associated risks.
This new Tech Transfer Advisory Service helps university-based technologies avoid the “valley of death” by providing actionable assessments of the regulatory and clinical landscape, grounded in professional experience with funding, intellectual property, and contracting considerations unique to university settings.
The CRS team specializes in translating complex regulatory expectations into clear, actionable steps that enable research teams to sharpen development strategies and advance more efficiently toward clinical and commercial milestones, including:
Regulatory Strategy
CRS conducts regulatory pathway assessments (RPAs) for medical devices and develops target product profiles (TPPs) for drugs that include research on state-of-the-art technologies and comparisons to existing U.S. market predicates to support a strong case for substantial equivalence. Assessments are based on device description, mechanism of action, intended use, and indications for use. This approach helps universities confidently address questions from potential investors and partners.
Early FDA Interactions
Through FDA programs such as Q-submission, Pre-IDE, INTERACT, and Pre-IND, CRS de-risks early development strategies while technologies remain within the university setting. This early interaction with the FDA positions universities to engage in informed discussions with potential partners and investors and to focus development towards commercial success.
Clinical Strategy
Potential investors and partners often ask whether clinical studies are required and what impact these requirements have on cost and timelines to commercialization. CRS helps estimate these costs and timelines and engages with the FDA to obtain early feedback to de-risk the overall development strategy.
Investor Relations
CRS distills the regulatory and clinical strategy, incorporating FDA feedback when appropriate, and helps develop presentation decks designed to capture potential investors’ attention.
Partnering
CRS helps identify and engage potential partners to develop relationships and assist in contracting conversations.
Gap Analysis
University faculty and tech transfer offices often ask “how much more” is needed to reach a particular milestone. CRS performs gap analyses, based on existing development strategies and the current opinions of the industry, to provide clear answers to address these questions.
Business Development
Across many of our service areas, CRS helps identify a streamlined pathway to the clinic and/or commercialization to de-risk potential pitfalls from an early stage.
WHAT OTHERS ARE SAYING
MOVE YOUR TECHNOLOGY FORWARD WITH CONFIDENCE AND ALIGNMENT
Contact Julie Cramer, PhD of CRS for a free introductory 30-minute consultation.
WE’RE HERE TO HELP YOU SHARPEN YOUR IDEAS AND THRIVE
CRS is actively involved in mentoring university innovation teams and judging healthcare competitions. We encourage our life science entrepreneurs and mentees to use human-centered design to refine and sharpen their ideas.
Clinical Research Strategies Proudly Supports Local Accelerator and Innovation Engines
Central New York Biotech Accelerator (CNYBAC) Service provider
CNYBAC is an off-campus accelerator serving for-profit pharmaceutical, biologic, and medical device startup companies who are actively commercializing a biotech-related product or service. CNYBAC is operated by SUNY Upstate Medical University – the region’s only academic medical center – and is located in close proximity to Syracuse universities and hospitals.
CRS is a Service Provider Network member offering Regulatory/Compliance, Risk Management/Quality Systems, Startup Company Support, and University Support services.
M2D2 IMPACT Program!
IMPACT is a 12-week accelerator program that uses a unique 1:1 approach and is created to connect startups with resources needed for commercialization. Selected companies will have the opportunity to engage with our corporate sponsors.
If you participate in the IMPACT Accelerator Program, you’ll access:
- Educational workshops and seminars tailored to your innovation
- Expert mentorship from leaders in the LifeSciences industry
- Prizes and resources worth thousands from healthcare organizations interested in your technology
LifeX – Accelerating Life Sciences
LifeX drives the development and growth of early-stage life science companies and growth of life sciences startups in Pittsburgh and across the country. LifeX is a capital growth company that de-risks time, resources, and investment for life sciences companies. They focus on the strategic pillars of commercialization, capital, infrastructure, and resources to create alignment and achieve the highest probability of success.
Their culture is made up of individuals who are highly committed to each company as they implement their defined commercialization process specific to their business strategy.
CRS Proudly Supports University ARPA-H Programs
The Advanced Research Projects Agency for Health (ARPA-H) supports programs with the potential to transform health care and accelerate better health outcomes. Each ARPA-H program focuses on a specific challenge that aligns with the agency’s broader research and development goals.
CRS is proud to be a value-add stakeholder in the Pittsburgh life sciences ecosystem, already supporting two ARPA-H Programs with Carnegie Mellon University. ARPA-H involvement helps attract funding for some of the most innovative technologies aimed at addressing major challenges in disease detection and treatment.
CRS is a Spoke Member of the ARPA-H Customer Experience Hub
As part of the Advanced Research Projects Agency for Health’s (ARPA-H) nationwide health innovation network, the ARPANET-H Customer Experience Hub targets prevention, treatment, and diagnosis needs through a proactive approach that diversifies clinical trials, engages representative patient populations, and promotes patient-centric approaches to improve health outcomes for Americans.
As an ARPA-H Customer Experience Hub Spoke, CRS is part of the consortium of organizations that offer capabilities, innovation, R&D, and population access to drive better health outcomes.
As an MTEC Member, CRS Supports the Advancement of Ideas that Improve Military and Civilian Health
The Medical Technology Enterprise Consortium (MTEC) is a DoD-focused nonprofit that funds medical technology development. Operating under a government-awarded Other Transaction Agreement (OTA)—a flexible contracting vehicle—MTEC can move faster, collaborate more freely, and engage a broader range of innovators.
MTEC drives military-civilian partnerships and fosters collaboration across an extensive ecosystem of small and large businesses, federal agencies, academic institutions, and more. The organization rapidly deploys funding to advance innovative medical technologies that improve outcomes for both military and civilian populations worldwide.