Tag Archives: stony brook university

CFB Announces New Bioentrepreneur & Executive-In-Residence

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The Center for Biotechnology at Stony Brook University has announced the appointment of Dr. Mario R. Mendoza as Executive-In-Residence, and Dr. William Mann as its newest BioEntrepreneur-In-Residence (BEIR). Drs. Mendoza and Mann have extensive bioscience industry experience affording them unique perspectives in their respective roles in residence at the Center for Biotechnology (CFB). Each will work with the CFB and the Long Island Bioscience Hub (LIBH), a collaboration between Stony Brook University, Brookhaven National Laboratory, Cold Spring Harbor Laboratory, and the Feinstein Institute at Northwell Health. Dr. Mann will identify commercially promising academic technologies that have the potential to support company formation while Dr. Mendoza will serve in an advisory capacity for bioscience startup companies in the hub.

Dr. Mario R Mendoza is a clinical anesthesiologist (practiced at the NIH) and currently a healthcare and pharmaceutical industry medical/medical affairs consultant with over 13 years of combined experience in patient clinical care, clinical development, R&D, medical affairs (Abbott, Pfizer and Centrexion Therapeutics), and FDA medical devices regulation. Dr. Mendoza earned his BS degree in chemistry from SUNY College at Old Westbury, and a MS in organic chemistry from the University of Illinois at Urbana-Champaign. He earned his M.D. from the University of Illinois at Chicago College of Medicine and then completed an FDA Commissioner’s Fellowship Program and stayed on at FDA as a Medical Officer/Medical Consultant.

Dr. William R. Mann is Principal of Lodestar Biopharma Solutions LLC, which assists clients in the development of R&D strategies for regulatory and commercial success, business development, and M&A. Previously, he was President and CEO at Helsinn Therapeutics (US), where he transformed the sixteen employee R&D start-up into a profitable commercial company with a team of over one hundred. At Sapphire Therapeutics, Dr. Mann facilitated an investor exit through M&A while managing the company’s lead clinical development program. He also held leadership positions at Novartis in R&D and business development. Dr. Mann holds a PhD in biochemistry from the University of Aberdeen, Scotland and an MBA from Rutgers University.
“We are excited to have Mario and Bill join us at the Center for Biotechnology. Their extensive and varied industry experiences are wonderful assets to our program. The further expansion of our BEIR Program allows us to continue to advance our agenda, fueling the developing bioscience industry in the region” Diane Fabel, Director of Operations at the Center for Biotechnology said.

“I’m thrilled to become an Executive-in-Residence for the Center for Biotechnology.” stated Dr. Mendoza “I’m greatly looking forward to getting involved with biotech industry innovators collaborating with the organization. I believe the bioscience community in the region is robust and the support and partnership with organizations like the Center for Biotechnology are critical in driving innovation in the biotech space, and in getting innovative patient-centric products to market for the benefit of the patient and healthcare provider communities.”

“The work of the Center for Biotechnology is incredibly important to the bioscience community in the region, and I’m eager to be joining the organization.” Dr. Mann stated. “The innovation potential within the region is immense, and I look forward to the collaborative opportunities that lie ahead.”

Dr. Mann will work to identify a technology or technologies from within LIBH partner institutions that will create the foundation for licensing and company formation. He will have the support of the Center for Biotechnology business and technology development staff, as well as the support of external industry advisors to develop successful commercialization strategies. Ultimately, the goal is to help the company position itself for SBIR/STTR grant opportunities, as well as Angel and VC investment. In his role as Executive-in-Residence, Dr. Mendoza will offer invaluable support to the CFB client company portfolio by providing guidance and expertise in diverse areas including, but not limited to, product development, intellectual property strategy, regulatory affairs, capital formation, medical affairs and reimbursement.

The addition of Drs. Mendoza and Mann marks ten entrepreneurs and two executives-in-residence working with the Center for Biotechnology under their BIER program. Collectively, the Center for Biotechnology BEIRS have launched twelve new companies since the program’s inception in 2013.

View PDF announcement. 

Free Course from NIH: Entrepreneurial Finance for Biomedical Innovators

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The course is presented in a series of five sequential videos. The video modules and course details can be found here: https://www.nibib.nih.gov/entrepreneurial-finance-course

The National Institutes of Health (NIH) supports the development and commercialization of biomedical technologies through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. With the goal of bringing life-saving innovations to market, NIH SBIR/STTR funding provides early-stage seed capital to US-owned small businesses. While the commercialization of biomedical technologies can require a significant amount of both time and money, rigorous financial planning can help navigate and mitigate risks for small businesses and can enhance chances of success along the pathway to market. For biomedical innovators considering funding through the NIH SBIR/STTR programs (https://sbir.nih.gov), it is imperative to evaluate the use of federal grant funding within the context of a broader financial plan.

Course Objectives
The purpose of this course is to present biomedical entrepreneurs with a detailed framework for building a step-wise, validated financial plan. Moving beyond the short-term perspective of immediate financing needs to a comprehensive, long-term financial plan will increase the probability of success for your venture. The primary learning objectives for this course are as follows:

– Understand the importance of financial planning for your small business
– Gain perspective on SBIR/STTR funding within the broader context of your financial plan
– Learn practical approaches to developing a long-term financial plan
– Evaluate the various sources of funding
– Examine the use of comparables in validating your financial plan

 

Funding Opportunity: BARDA DRIVe EZ-BAA

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As a BARDA DRIVe Accelerator, the Center for Biotechnology is pleased to announce that the simplified funding application process, called EZ BAA, is now open. Medical product developers, research teams, and companies offering disruptive solutions to health security threats are invited to submit abstracts beginning today using this simplified EZ BAA process.

Applications accepted through this streamlined process must offer transformative innovation, products and technologies to protect Americans from health security threats. This application process is a business friendly simple abstract.

In-scope priority areas include products and solutions to reduce illness and death from sepsis as part of DRIVe’s Solving Sepsis initiative; technologies and processes to identify infections and exposures to biological and other health threats, as outlined in the Early Notification to Act, Control, and Treat (ENACT) initiative; and tools and techniques to mitigate the damages and loss of life associated with catastrophic events.

Applying is simple:

  • Download the application form the DRIVe website.
  • Submit a technical abstract no longer than a 2,000 words
  • Include a cost proposal of an additional 2,000 words or less.
  • Proposed costs should not exceed $749,000.

What happens next:

  • Once submitted, DRIVe’s experts will review the application to ensure it is within scope and meets DRIVe criteria.
  • As the applicant, you’ll be notified of the review results within 30 days of your submission.

**The Center for Biotechnology is interested in working with potential applicants to help ensure the submission of a robust on-target proposal. If you are interested learning about how the Center for Biotechnology can help, please contact William Hanes: william.hanes@stonybrook.edu***

Learn more about the DRIVe EZ-BAA review criteria here.
Have questions? Looking more information? Contact DRIVeContracting@hhs.gov

Long Island Bioscience Hub Appoints Additional BioEntrepreneurs-In-Residence

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Seasoned Industry Veterans Join Long Island Bioscience Hub’s BioEntrepreneur-in Residence Initiative

The Long Island Bioscience Hub, a collaboration between Stony Brook University, Brookhaven National Laboratory, Cold Spring Harbor Laboratory, and the Feinstein Institute at Northwell Health, announced the appointment of Dr. Boris Shor and Mr. Peter Young as its newest BioEntrepreneurs-In-Residence (BEIRs). Dr. Shor and Mr. Young have extensive bioscience industry experience affording them unique perspectives in the role of Bio Entrepreneur-in-Residence. Each will work with the Center for Biotechnology to identify commercially promising academic technologies that have the potential to support company formation.

Dr. Shor has nearly 15 years of experience in leading oncology programs and external R&D partnerships at the large pharmas and biotech companies, with specific focus on preclinical development of small molecule kinase inhibitors and biologics. Previously at Pfizer, Dr. Shor led internal and external collaboration project teams to develop novel antibody-drug conjugates and supported BLA filing for Inotuzumab, which was approved for the treatment of leukemia in 2017. Prior to that, he was a project team leader at the Oncology Unit of Wyeth, managing the discovery of novel kinase inhibitors for the treatment of cancer. He currently serves on the executive management team of early-stage biotech companies and is a founder of BioIDEA, a biotech pitch event in New York City. Dr. Shor received a Ph.D. in Molecular and Cell Biology at the State University of New York Downstate Medical Center and performed a postdoctoral fellowship in the Inflammation Research team at Johnson & Johnson Pharmaceutical R&D prior to joining Pfizer.

Mr. Young is an experienced life science industry consultant with over thirty-five years experience and currently serves as an executive-in-residence with Pappas Capital, where he leads the firm’s initiatives in translational research. He also serves on the Oversight Committee for the University of Miami Wallace H. Coulter Center for Translational Research and the Long Island Bioscience Hub External Review Board. He is a past member of the BIO board and chairman of NCBIO, the North Carolina industry trade association. Mr. Young earned a BA in History and an MBA from Indiana University.

“We couldn’t be more delighted to add Boris and Peter to the Center for Biotechnology’s roster of BioEntrepreneurs-in-Residence. The ongoing expansion of the BioEntrepreneur-in-Residence program is critical for the continued development of the bioscience industry in the region” Diane Fabel, Director of Operations at the Center for Biotechnology said. “The attraction and retention of skilled bioscience management talent is an important component of ensuring companies can be launched and also grow here.”

“I am thrilled to join the Center for Biotechnology as a BioEntrepreneur-in-Residence” Dr. Shor stated, “and I have already begun the work of assessing technologies and building a company. I appreciate the resources the Center for Biotechnology offers through their many programs not only to me, but to emerging companies throughout New York.”

“Having worked with the Center for Biotechnology as an advisor for several years, I am pleased to formally join the Center as BioEntrepreneur-in-Residence” Peter Young stated. “There is an incredible amount of activity related to bioscience development currently taking place right now in the region, and the Center’s many entrepreneurial programs provide a great springboard for significant industry expansion – I’m thrilled to be a part of it.”

In their roles as BEIRs, Dr. Shor and Mr. Young will work to identify a technology or technologies from within partner institutions that will create the foundation for licensing and company formation. They will have the support of the Center for Biotechnology business and technology development staff, as well as the support of external industry advisors to develop successful commercialization strategies. Ultimately, the goal is to help the company position itself prepare for SBIR/STTR grant opportunities, and Angel and VC investment.

Dr. Shor and Mr. Young join the eight BEIRs already working with the Center for Biotechnology who collectively have launched ten new companies in the last five years.

Client News: First In-Human Clinical Trial Targeting CD4 Protein for Aggressive T-cell Leukemia and Lymphoma to be Launched

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Stony Brook University, iCell Gene Therapeutics and University of Louisville collaborate to offer a new CAR T immunotherapy to treat patients.

Stony Brook University, iCell Gene Therapeutics, and the University of Louisville, have received Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) for the treatment of relapsed and refractory T-cell leukemia and lymphoma. The approach is the first to use chimeric antigen receptor engineered T-cells directed against the target protein CD4 (CD4CAR). Together, Stony Brook University, the University of Louisville, and iCell Gene Therapeutics expect the first in-human Phase I clinical trial to begin accruing patients before the end of 2018.

“We are excited to partner with the University of Louisville and iCell Gene Therapeutics to offer this innovative first-in-human CAR T cell immunotherapy clinical trial for patients who are suffering from these extremely difficult to treat T cell lymphomas and leukemias,” said Huda Salman, MD, Principal Investigator for the IND and an oncologist at Stony Brook University Cancer Center. “CD4CAR T cells may prove to be a promising and novel therapy in this setting.”

“The development of this trial using CD4 as a target is the first of what we expect to be many CAR T-based clinical trials available to our patients over time,” said Yusuf Hannun, MD, Director of the Stony Brook University Cancer Center. “The pending trial is an example of the type of bench-to-bedside research that is building up at Stony Brook due to the growing expertise and collaborative research environment we are creating and new opportunities that will emerge upon the opening of our Medical and Research Translation (MART) Building.”

William Tse, MD, FACP, Chief of the Blood and Marrow Transplantation at the University of Louisville School of Medicine, is the Co-PI of the CD4CAR clinical trial at University of Louisville site.