The Forsyth Institute presents: Only Orphans COTE – Delivering Drugs through the FDA and EMA
Date and time: Thursday, October 21, 2021
3:00 PM – 4:30 PM Eastern
Zoom link provided upon registration.
About this event
Got an idea for a new drug for a wicked rare disease? How do you move from idea to fantasy to pharmacy? More specifically, who are those people at the FDA and how can you best engage with them without losing momentum?
Timothy Cote MD MPH is the newly-arrived Entrepreneur-in-residence at the Forsyth Institute, based in Cambridge MA. He will be hosting a monthly in vivo cum in silico seminar series to discuss topics in orphan drug development with an emphasis on regulatory affairs in the US and Europe. With more than 15 years of experience in the field, Dr. Cote was previously the Director of FDA’s Office of Orphan Products Development. In that capacity he personally signed 1,400 orphan drug designation decisions and saw 140 orphan drugs go to full marketing authorization.
FDA has some special perks of extraordinary value. Learn how you qualify, what they give you and how to apply.
Register for this event.
Message from the Standard Coordinating Body (SCB)
The SCB is working on some exciting new initiatives this quarter and need your input to help ensure they are valuable and meaningful to the community.
Regenerative Medicine Lexicon
The SCB Standards Development Forum Lexicon working group is developing a reference guide to clarify commonly confused regenerative medicine terms. This resource will cover terms that are defined differently by different SOOs and stakeholder groups and provide guidance on how to choose the definition that best fits your needs. The resource is intended to improve clarify of communication and help harmonize the language used in standards.
Provide your input on terms in need of clarification.
The Standard Coordinating Body Working Group Spotlight: Characterization of Human Cells for Therapeutic Use
The Standard Coordinating Body for Regenerative Medicine-coordinated working group helped accelerate the standards development process, resulting in the publication of ISO 23033: General Requirements and Considerations for the Testing and Characterization of Cellular Therapeutic Products.
Learn more about the working group. ______________________________________________________________________________________________________________
The next Bench2Market Talk topic on October 27th covers Translational Funding Opportunities and will include a panel of funders who will discuss their available resources for innovators and highlight what technology types and development stages are most appropriate for their funding opportunities. You can learn more about the speakers and register to attend for free at https://bit.ly/B2M_October2021.
The Materials Research Society (MRS) and the Society For Biomaterials (SFB) are excited to announce a new collaboration in delivering education to our members. SFB & MRS will present a webinar each Tuesday in October 2021 (5th, 12th, 19th, 26th) at 11:00 am ET.
Topics (and dates) include:
October 5 – 3D Printing for Medical Applications:
October 12 – Translational Bioelectronics:
October 19 – Machine Learning (ML) and Artificial Intelligence (AI) in Biomaterials Design and Development:
October 26 – Biomaterials Science and Engineering to Address Unmet Needs in Women’s Health:
For more information and to register for these webinars here.
*Registration for all four webinars is only $150 for SFB and MRS Members! (Half price for student members!) You can also register for each webinar separately for just $50 a session.*
Osteo Science Foundation’s 2021 Webinar Series presents John R. Zuniga, DMD, MS, PhD, who will present Advances In Peripheral Nerve Repair and Regeneration followed by a Live Q&A on Tuesday, October 12, 2021 at 8:00 P.M. Eastern
Register Now to reserve your spot!
The Biointerfaces Institute (BI) is seeking applications for an inaugural cohort of BI Innovation Fellows. The Innovation Fellowship is a full-time position for up to two years at a competitive $60,000 salary with full benefits. The program offers a unique opportunity for Fellows to be embedded within the BI research and translational ecosystem to explore research commercialization.
For more information and to apply go to the Biointerfaces Institute website.
Applications are due on Friday, October 15, 2021.
a2Tech360 kicks off this Friday, October 1, 2021 in Ann Arbor, Michigan. This is a hybrid event that includes both virtual and in-person options for registrants. For more information, see the event on our calendar page here. To register for this event, go to the a2Tech360 website.
The USC/CHLA Cell Therapy Program Seminar Series: “Delivering on the Promise of Cell & Gene Therapy” is being held virtually on Monday, November 22, 2021 from 12pm to 1pm.
The presenter will be James (Jay) Bradner, M.D., President of the Novartis Institutes for BioMedical Research (NIBR).
For more details and to register, check out the event on our calendar here.
The USC/CHLA Cell Therapy Program Seminar Series: “The Clinical Translation of Cell and Gene Therapies: Q&A” is being held virtually on Friday, October 29, 2021 from 12pm to 1pm Pacific Time (3pm to 4pm Eastern).
The presenters will be Mohamed Abou-el-Enein, MD, PhD, MSPH
Associate Professor of Clinical Medicine, Pediatrics, and Stem Cell Biology & Regenerative Medicine, Executive Director, Joint USC/CHLA Cell Therapy Program and Magdi Elsallab, MD, Regulatory Affairs and Clinical Development Specialist, Joint USC/CHLA Cell Therapy Program.
For more details and to register, check out the event on our calendar here.
The Society For Biomaterials’ 2022 meeting website is now online at:
The Society For Biomaterials is excited to host the 2022 Annual Meeting at the Baltimore Marriott Waterfront April 27-30, 2022 in Baltimore, MD. In keeping with the history of our host city, the theme for the SFB 2022 Annual Meeting is “The Perilous Fight to Translate Innovative Research to Commercial Viability“. This years program is focused on ideas that involve breakthroughs in biomaterials science, translation of basic research to clinical application, next generation medical devices, and content that explores standards development, regulatory issues and commercial realities.
The abstract submission deadline is October 25, 2021 at 11:59 PM EST ($25 submission fee) OR November 10, 2021 at 11:59 PM EST ($50 submission fee).
Call for Abstracts
Abstracts are being solicited for the Society For Biomaterials’ 2022 Annual Meeting. The scope of each general session and symposium is available on the SFB 2022 Annual Meeting Web site: https://2022.biomaterials.org/
The online abstract submission site has an extensive list of keywords and topics that will help determine how your research fits within the scope of this conference. Simply visit the SFB 2022 Annual Meeting web site at https://2022.biomaterials.org/ where you will find information on abstract submissions, Baltimore, and more!
Please contact the Society For Biomaterials headquarters office with any questions or concerns.
Submit your most outstanding Soft Tissue Thickening case now until Sunday, October 31, 2021 on THE BOX. The authors of three cases selected by the jury will be invited to present their case in a webinar on December 9, 2021, where our expert panel consisting of Mariano Sanz and Daniel Thoma will select the overall winner.
More information and the instruction on how to participate in the 5th Osteology Case Competition is available here.
The First DOCTRC Innovator Networking Series event will take place on Tuesday, October 26, 2021 3PM Eastern/12PM Pacific. See the flyer for more details on how to join.
JDR and IADR highlight the Special Issue: Interface Between Materials and Oral Biology, featuring an article by the MPWRM Resource Center. Click here for the JDR interview with Resource Center PI Dr. David Kohn.
The International Space Station Research and Development Conference 2021, which is taking place this week, includes a fireside chat with McGowan Institute Director William Wagner about the opportunities for biomanufacturing in space, particularly in the fields of tissue engineering and regenerative medicine. A preprint
(not yet peer-reviewed) of their research was posted online this week.
The 10th annual International Space Station Research and Development Conference (ISSRDC)
Aug 3-5, 2021
Resource Center, PI, Dr. William Wagner will be a panelist at the 2021 International Space Station Research and Development Conference (ISSRDC) on Tuesday, August 3rd at 1:30pm, which will feature a fireside chat on biomanufacturing in space. Gary Rodrigue, director of programs and partnerships at the Center for the Advancement of Science in Space (CASIS), will moderate a discussion with Dr. William Wagner, director of the University of Pittsburgh’s McGowan Institute for Regenerative Medicine. The discussion will focus on the value of space-based biomanufacturing and the critical role of the orbiting laboratory in advancing this research area. biomanufacturing and the critical role of the orbiting laboratory in advancing this research area. Registration is free.
Apply for the new BII & Science prize for innovation today!
Deadline: November 1, 2021
For more details and directions to apply, go to BioInnovation Institute & Sciences website.
Behind every life-changing solution is an entrepreneurial scientist. A creative mind who proved an idea in the lab and dared to carry it out in the world.
To encourage more scientists to translate their research, BioInnovation Institute (BII) & Science present a new annual award.
Our three winners will have their essays published in Science magazine and will be invited into BII’s entrepreneurial ecosystem. In addition, the Grand Prize winner will receive a prize of USD 25,000 and each runner-up will receive USD 10,000 at a grand award show celebration in Copenhagen, Denmark.
The Forsyth Institute, with its 111-year history of oral health innovation, presents Forsyth dentech 2021—the leading oral health technology innovation conference convening thought leaders from research, industry, academia, and venture capital. This annual event aims to accelerate innovation and launch new ventures in the oral health space. The selected presenters will have the stage to showcase their exciting new technology or pitch their business proposals for funding support. Investors and dental companies will be able to review some of the most innovative dental technologies for investment or licensing opportunities. The conference will also offer cash prizes to top technologies that will be chosen by the organizing committee.
Orthopaedic Research Society’s Abstract submission is now open!
Abstract Submission Deadline: Monday, August 30, 2021
For details and to submit your abstract, go to the ORS’s abstract page here.
If you have questions, email ORSabstracts@ors.org.
SFB-TERMIS Panel – “Picture a Scientist”
The Society for Biomaterials (SFB) is partnering with the Tissuse Engineering and Regenerative Medicine International Society (TERMIS) to host a discussion on the issues presented in the recent documentary “Picture a Scientist” on Thursday, July 29, 2021 at 12 noon Eastern.
Register at the link below.
Submit an Abstract for the ORS 2022 Annual Meeting!
We’re looking forward to welcoming you to Tampa, Florida for the ORS 2022 Annual Meeting, February 4 – 8, 2022. Tampa will be the perfect setting for our in-person meeting by providing a beautiful convention center located downtown on Tampa Bay with great restaurants and ample extracurricular activities nearby. Scientifically, the meeting promises to be another outstanding event with the Program Committee finalizing the selection of the scientific program, Research Sections planning their meetings, and looking forward to your research being submitted for presentation.
We do realize that not all the ORS community may be permitted to travel due to imposed travel restrictions (government or institutional). However, ORS will provide the opportunity for those unable to travel to present their work. Details are included here https://www.ors.org/2022-call-for-abstracts/.
Deadline for submission is August 30, 2021.
New! Abstracts Login!
In the past authors have logged in directly to the abstract submission site. Starting this year, you will login to the abstract submission system via your ORS login at https://ors.memberclicks.net/abs22.
To start, submit, or edit your abstract(s), you will need to login here https://ors.memberclicks.net/abs22#/ using your ORS username and password.
The Society For Biomaterial (US) and the Japanese Society for Biomaterials are hosting a Joint Symposium that will highlight the seminal work of four Pioneers in the biomaterials field on January 8-10, 2022 in Honolulu, Hawaii!
The call for abstracts is now open on the Society for Biomaterials website. Please go here for abstract information and to submit your abstract. Check out the full meeting webiste here. The deadline to submit your abstract is September 1, 2021 at 11:59pm (EST). (There is a $10 submission fee).
Abstracts for an oral or poster presentation are being solicited in four general session areas:
- Implant Pathology & the Foreign Body Reaction
- Polymeric Biomaterials
- Bioglasses / Ceramics
- Tissue Engineering
Applications for the second cohort of AlphaLab Health are Open! Apply here by July 16th for Priority Consideration.
AlphaLab Health is a pre-eminent healthcare and life sciences accelerator which supports early-stage startups.
Started last year by Innovation Works and Allegheny Health Network, AlphaLab Health provides selected participants with up to $100,000 in funding, expert guidance navigating the health care system and developing a robust commercial strategy, mentorship with industry leaders, wet and dry lab space, access to clinicians, and an extended network of potential funders and customers.
This six-month program will begin in mid-October 2021.
Resource Center member Dr. Sam Lynch on Humans in Healthcare Podcast: Dr. Sam Lynch – Founder and CEO – Translational Medicine, Challenges of the U.S. Healthcare Regulatory Environment, and Founding an Education Nonprofit for Underprivileged Students
The Resource Center publishes a white paper entitled Translating Dental, Oral, and Craniofacial Regenerative Medicine Innovations to the Clinic through Interdisciplinary Commercial Translation Architecture in Journal of Dental Research.
ITP program Call for Proposals is currently open: Pre-Proposals due June 1, 2021. (Call for pre-proposals are now closed)
MPWRM Resource Center Co-Principal Investigator Dr. David Mooney’s work on surgical adhesive is featured on NIDCR’s newsletter. Click here for more.
Click here to check out ITP Team RevBio’s work with Tetranite® for local delivery of non-addictive pain medicine funded by NIH’s HEAL initiative.
Current Oral Regeneration Topic: Vertical Ridge Augmentation | Webinar
Speaker: Luca De Stavola, Italy
Moderator: Tali Chackartchi, Israel
LIVE WEBINAR: 19 April 2021, 18:00 GMT
For additional information, click here.
- Registration for the 2021 Society For Biomaterials Virtual Annual Meeting is now open. Click here for additional details.
- Rock Stars of Regenerative Engineering (April 19-20, 2021, Virtual). Regenerative Engineering Society of American Institute of Chemical Engineers presents this event that will cover a range of topics on regenerative engineering. This event is proudly virtually collocated with the 2021 Society for Biomaterials Annual Meeting and Exposition (https://2021.biomaterials.org/). Click here for additional details.
Congratulations to Dr. Luiz Bertassoni – a recipient of the Oregon Health and Sciences University’s Faculty Excellence and Innovation Awards program! Click here for the full story.
Diversity in STEM Panel
: Hosted by The Innovation Hub and Women Accelerators on Wednesday, March 10, 2021 from 12pm-1pm. As a way to celebrate #InternationalWomen’sWeek, this panel will address issues of diversity in academia, engineering, other STEM fields, the workplace and much more.
The Force Family Office will be hosting MIT Professor, Founding Moderna Investor and most cited engineer in history, Dr. Robert Langer for a discussion on “The Future of Regenerative Medicine” with EpiBone CEO Nina Tandon, PhD, MBA. This event will take place on March 16, 2021.
See the rest of the press release here
Nov 2- 4, 2021
Translational Consult Program launched! For additional information, please see here
2020 Media Releases
Academy of Osseointegration: Now accepting research abstracts for 2021 Annual Meeting (March 11-13, 2021), due October 2, 2020. Click here
for more information.
LaunchPad Medical Rebrands as RevBio and Launches an Updated Website
Dr. David Kohn named as the Natalie C. Roberts Professor of Dentistry at the University of Michigan. Congratulations!
Call for Abstracts are now open for the Academy of Osseointegration Annual Meeting, March 10-12, 2021. Deadline for abstract submissions: Friday, October 2, 2020 11:59 PM (CT). For more information, see https://osseo.org
Wins a $2.5 Million NIH Grant to Improve Cranial Procedures. For additional information, see the press release here
Join and hear from keynote speakers David Mooney of the Wyss Institute at Harvard University and Melody Swartz of the Pritzker School of Molecular Engineering at University of Chicago along with graduate student presentations in the field of regenerative medicine and transplant.
Dr. Michael Passineau, one of the ITP principal investigators, will give a keynote at a plenary session entitled “Restoring Salivary Glands Function with Gene Transfer Therapy: Turning the Impossible into Reality” at the 2020 American Academy of Oral Medicine Annual Conference in Orlando, Florida on April 29–May 2, 2020.
Dr. Will Giannobile will give a keynote presentation entitled “Tooth Preservation Versus Implants Through Regenerative Technologies” in an interdisciplinary session at AAE20, American Association of Endodontists’ Annual Meeting in Nashville, Tennessee on April 1-4, 2020.
New podcast series available from Osteology Foundation: “Podcast – Legends of Oral Regeneration“!
In the first episode of the new podcast, MPWRM Resource Center PI and Osteology Foundation President William V. Giannobile, talks to Myron Nevins.
An application from our ITP principal investigator Dr. Kacey Marra was accepted for Equalize 2020, the nation’s first pitch competition for women academic inventors, forming university startups. Congratulations!
2019 Press Releases
LaunchPad Medical Accelerates Enrollment in its First-In-Man Clinical Study of Tetranite® for Dental Implant Stabilization. Please see here for the press release
Congratulations to Resource Center Principal Investigators and members, Drs. David Kohn, Will Giannobile, Jan Stegemann, and Lonnie Shea for receiving the University of Michigan’s Biosciences Initiative award. Click here and here for more information.
Congratulations to MPWRM Resource Center Co-Principal Investigator Dr. David Mooney on being ranked in top 0.1% of cited researchers for the year! Click here for the full story.
LaunchPad Medical Wins NIH HEAL Grant to Reduce Opioid Use and Addiction. For additional information, see the press release here.
Congratulations to our Resource Center member, Dr. Darnell Kaigler, on being named the Major M. Ash Collegiate Professor of Periodontics at the University of Michigan! Click here for the story.
LaunchPad Medical, one of the ITP teams, initiates a clinical trial to examine the safety and efficacy of the its bone adhesive biomaterial, Tetranite®, for the stabilization of dental implants for tooth extractions. For additional information, see the press release here.
GreenMark Biomedical Secures Phase II SBIR Funding for Identification of Early Stage Dental Caries. Click here for the full story and the press release.
Congratulations to Dr. Bill Wagner, Director of the McGowan Institute for Regenerative Medicine, who was appointed Distinguished Professor of Surgery in the University of Pittsburgh School of Medicine. See here for more information.
Standards Coordinating Body is working on a standards project regarding Standards Webinars for Translational Medicine Researchers. this is an education and outreach with the National Institutes of Standards Technology (NIST); National Cancer Institute; and the Standards Coordinating Body Cell Therapy, Gene Therapy and Tissue Engineering Sector Working Groups. For more information, see here.
Congratulations to MPWRM Resource Center Co-Principal Investigator Dr. William Giannobile on being elected as next Osteology Foundation President! Click here for the full story.
University of Michigan invests $500,000 in GreenMark Biomedical, Inc. (Cycle 2 ITP awardee) through Michigan Investment in New Technology Startups initiative.
For more information, please see: https://record.umich.edu/articles/u-m-invest-20-million-four-its-startups
New FDA Guidance on Regenerative Medicine
FDA recently released 2 new guidance documents on regenerative medicine therapies:
Click here to see the press release.
LaunchPad Medical (Cycle 1 ITP awardee), raises $8.5M in a recent round!
For more information, please see: https://www.massdevice.com/bone-adhesive-dev-launchpad-medical-raises-9m-medtech-funding-roundup/
2018 Press Releases
Congratulations to Michigan-Pittsburgh-Wyss Resource Center Principal Investigator Dr. William Giannobile on winning the Ross Award given by the American Dental Association! Check out the full press release here.
Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center @ the University of Michigan’s Translational Funding Fair!
Representatives from 25 translational funds at the University of Michigan were present to provide inventors the opportunity to learn about resources and programs available to advance innovation into the marketplace. Check out the video here!
Check out the Practicum presentations from our first Annual Stakeholders’ Summit (July 10-11, 2018)
Regenerative Medicine Innovation Project Funding Opportunity announced:
Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Studies (Collaborative U01 Clinical Trial Not Allowed)
Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
Regenerative Medicine Innovation Projects (RMIP) (UT2 – Clinical Trial Not Allowed)
Regenerative Medicine Innovation Projects (RMIP) (U44 – Clinical Trial Not Allowed)
Click here, for more information.
Interview with RegMedNet: The Regenerative Medicine Resource Center: supporting pre-clinical interdisciplinary dental, oral and craniofacial projects.
Dr. Almarza’s review entitled Preclinical Animal Models for Temporomandibular Joint Tissue Engineering published in Tissue Engineering Part B: Reviews
Just announced! MPWRM Resource Center releases Cycle 3 Interdisciplinary Translational Project program Request for Pre-Proposal Applications. Please click here for more information.
MPWRM Resource Center Principal Investigator Dr. William Giannoble’s research on Periodontal Tissue Engineering made the April 2018 issue of Compendium magazine
Osteo Science Foundation is pleased to announce the Spring 2018 submission cycle for the Peter Geistlich Research Awards. Click here for all the details and here to get started. See the flyer here.
MPWRM Resource Center was featured in American Association for Dental Research (AADR) News
Dr. William Giannobile, Editor-in-Chief of JDR celebrating
MPWRM Resource Center’s January 2018 Newsletter
Just announced! The MPWRM Resource Center will be hosting its First Annual Stakeholder’s Summit on July 10th and July 11th, 2018.
FDA announces comprehensive regenerative medicine policy framework
Regenerative Medicine resource center focuses on first projects