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    • 07 Apr 2020
    • 7:00 PM - 8:30 PM
    • FREE ONLINE WEBINAR

    ENET is pleased to present this event as a FREE online webinar!  Use the link below to pre-register!

    Register Here: https://bit.ly/ENET2915w

    Entrepreneurs’ today don’t need to build a manufacturing plant to start a business. They need less money to build prototypes, prove that it works, prove there is a market and show a potentially profitable business model before scaling. The road maps have changed but the core has stayed the same. Why will your customers buy it?

    Whether you want to sell a new kind of transportation system, a new app or a life saving device, you’ve got to develop your idea into a product that customers are willing to pay for. 

    ·         Do you try to develop the product in house, or do you outsource the development?

    ·         How do you fund your product development?

    ·         How do you make sure you’re developing the right product for your market? 

    The panelists have deep experience in developing and investing in different types of products in life sciences and high-tech. Our discussion will offer guidance in matching your product to your market and practical suggestions for making the most of your development budget. Listen to our speakers share a few stories from their own product development adventures and effective advice for avoiding product development pitfalls. 


    Agenda: 

    7:00 7:15 PM - ENET Chairperson's announcements

    7:15  7:30 PM - eMinute - Up to 3 Startup companies’ presentations

    7:30  8:15 PM - 2 expert speakers on the night's topic

    A question and answer session follow the presentation, and panelists will be available afterward for responses to individual questions. 

    Register Here: https://bit.ly/ENET2915w

    Panelists: 

    Joyce C. Chiu, PMP, CPIP, has 20+ years of experience leading large complex new product development under rigorous stage gate processes

    She has successfully taken products from initial R&D or design phase, through VOC (voice of customer), CTQ (critical to quality), PQA (product quality architecture), Requirements, Prototyping, Engineering, V&V (Verification & Validation), UAT (user acceptance testing) to global launch, utilizing best practices from PMP and Agile/Scrum, to achieve both "do it right the first time" and "do it fast".  Two of the products she provided leadership for earned independent industry awards the year after launch.

    Joyce will share the wealth and breadth of her product development experience in both the physical and the virtual worlds.  Her process development and program management experience spans specialty chemicals, single-use Bioprocess disposables, PPE (personal protection equipment), life sciences in both medical devices and biotechnology.  Most recently, she took on R&D IT projects serving Biopharma pre-clinical manufacturing and process development.  Joyce is a BS Chemical Engineer from Cornell University and an MBA from Babson College.  She has been active in greater Boston area professional organizations, including MDG and ISPE Boston Area Chapter.  As a CPIP she has served the latter in a variety of roles, including Industry Advisory Board and Program Manager for the 2019 Product Show Education Seminars

    https://www.linkedin.com/in/joycechiu/


    Harry Martins - Senior Manager, New Product Development at Bridgemedica - A Service of NN Life Sciences

    A product development leader with 25 years of medical device experience, he currently leads the New Product Development team at Bridgemedica with a focus on mechanical and electro-mechanical single-patient disposable medical devices.  Harry has developed products in the areas of orthopedics, biologics for neural and ocular surgery, vascular access, drug delivery, and pulmonary and endoscopic surgery while at Depuy Mitek/J&J, Cytotherapeutics, Biolink, Control Delivery Systems, Boston Scientific and Tissue Regeneration, Inc.  During his 8+ years at Bridgemedica, he has brought in or worked directly on products relating to female sterilization, laparoscopic hysterectomy, tissue morcellation, laparoscopic vessel ligation, targeted brain infusion, protein purification, spinal taps, tumor ablation, varicose vein sclerotherapy, lipoplasty, and fat grafting, laparoscopic imaging, and embolic delivery.  Harry holds or contributed to 28 issued U.S. Patents with 25 pending applications.  He has a BS in Mechanical Engineering from the University of Massachusetts, a MS in Mechanical Engineering from Stanford University, and a MS in Bioengineering from the University of Michigan.

    https://www.linkedin.com/in/harrymartins/


    Organizer and Moderator:

    Dan Skiba, President & CEO GOT Interface; Vice-Chair, Boston ENET

    As a Product Development Company Executive, I provide strategic leadership in product innovation and managing global teams, delivering award-winning products to the international market.  My ability to problem solve, direct the entire product development lifecycle and gain commitment to a common goal have driven faster release of products and market penetration.  By building synergies across all Product Life Cycle disciplines, we have delivered products that result in 100% product utilization and seamless integration into customer environments. My skills in optimizing international resources have significantly reduced costs and streamlined production, delivering product excellence.


    FURTHER INFORMATION:

    Location:

    Free Online Webinar

    Register Here: https://bit.ly/ENET2915w


    • 21 Apr 2020
    • 7:00 PM - 8:30 PM
    • FREE ONLINE WEBINAR

    ENET is pleased to present this event as a FREE online webinar!  


    Start-ups are hard work. Launching a start-up is difficult, time consuming and fraught with challenges and risks. Operating an emerging company to achieve financial success is also difficult and risky, with untold obstacles to success in product R&D, financing, operations, business development…and the list goes on. 

    If the day to day challenges of entrepreneurship seem daunting, life sciences entrepreneurs often have another (not so small) detail to contend with. Regulatory approval, through government agencies like the U.S. FDA and the EU’s EMA, may be required before a product reaches the market – requiring rigorous (and expensive) clinical trials and highly regulated manufacturing processes, among other details. 

    ENET is here to help; we’re all about offering practical insights, from experienced industry veterans, to help entrepreneurs to succeed. Tonight’s panel will offer insights on how to prepare for meeting rigorous regulatory requirements and even when to get started thinking about regulatory affairs.


    Agenda:

    7:00 7:15 PM - ENET Chairperson's announcements

    7:15  7:30 PM - eMinute - Up to 3 Startup companies’ presentations

    7:30  8:15 PM - 3 expert speakers on the night's topic

    A question and answer session follow the presentations


    Panel:

    Gail Radcliffe, President Radcliffe Consulting, Inc.

    Gail E. Radcliffe has more than 20 years experience assisting medical device and diagnostics companies with technical assessment, market research and clinical/regulatory issues.  Gail founded Radcliffe Consulting in 1998 after having worked at GENE-TRAK, where she developed IVD assays for several infectious disease organisms including HIV, CMV, TB and Chlamydia and was responsible for instituting the clinical affairs group.

    As a consultant, Gail has provided assistance to start-up and established medical device companies with market research, regulatory strategy (IVD vs. CLIA lab) and submissions, quality systems development and clinical trial support.   Consulting engagements have encompassed a wide range of products including cutting edge digital pathology instruments, stem cell laser dissection devices, companion diagnostics, and multiplex molecular, NGS, POC and CLIA Waived in vitro diagnostic devices.

    Gail obtained a Ph.D. in Molecular Biology from Brown University and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School.

    She is a member of the Regulatory Affairs Professional Society (RAPS), American Society of Microbiology (ASM) and Sigma Xi.  She is on the Board of Trustees of the Massachusetts Biomedical Initiatives and acts as an advisor to venture capital companies.

    https://www.linkedin.com/in/gail-radcliffe-13a0891/


    Kevin J. Slatkavitz, President and Founder, ThinkQuality, LLC

    Kevin is President/Founder of ThinkQuality, LLC – a strategic consulting firm providing clients across the life sciences with practical customized strategies, solutions and coaching to address a range of quality and regulatory compliance challenges and opportunities from early stage discovery through critical development milestones to product approval/launch and beyond.

    He has over 30 years of real world, boots-on-the-ground experience/insights into the complex and global rigors of small and large organizations and draws on over 10 regulatory product approvals (from Lipitorâ to Linzessâ) and many more investigational and commercial products from numerous therapeutic categories and delivery systems.

    What differentiates Kevin is his “fit-first-time” approach to integrating quality and regulatory compliance proactively and strategically with the science/technology into a client’s business plan as a means to demonstrate value to investors, regulators, patients and other key stakeholders.

    Kevin serves as a MassBio/MassConnect mentor for start-up companies.

    https://www.linkedin.com/in/kevinslatkavitz/


    PRAVIN R. CHATURVEDI, CEO and Co-Founder, Oceanyx Pharmaceuticals

    Pravin Chaturvedi is an experienced drug developer and a seasoned biotech entrepreneur. He is the Chairman of the Scientific Advisory Board for Napo Pharmaceuticals/Jaguar Health. He is the CEO of IndUS Pharmaceuticals and Oceanyx Pharmaceuticals. He is the Chairman of the Board of Cellanyx and also serves on the boards of IndUS, Oceanyx, ResoluteBio, Enlivity, MAG Optics, FuelEd Schools and Sindu Research Laboratories. He has previously served as the President and CEO of Pivot Pharmaceuticals and Scion Pharmaceuticals, and served on the boards of Pivot, Scion, Bach Pharma, PRADAN USA, Sindu Pharmaceuticals and TiE Boston. He was the Head of Lead Evaluation at Vertex Pharmaceuticals; and previously was at Alkermes and Parke-Davis/Warner-Lambert (now Pfizer). He has participated in the successful drug approval and commercialization of seven drugs indicated for the treatment of CNS, viral and gastrointestinal disorders. He is as an adjunct faculty member at Georgetown Medical School.

    https://www.linkedin.com/in/pravin-chaturvedi-a329392/


    Moderator/Meeting Organizer:

    Roger Frechette, Life Science Business Executive / Entrepreneur / Mentor – NEPAssociates, LLC

    My daily purpose is to exercise an innate drive to transform ideas and projects into life-changing commercial assets. In the life science business, this is the long game, requiring boundless energy and creativity, coupled with knowledge, experience, and patience.


    In my consulting work, I help clients as a business adviser or on-demand, fractional executive.  I leverage an extensive global network and insights derived from >20 years of experience in business development, calibrated with an extensive science background. My career
    has encompassed success as a business executive, project and strategic alliance manager, entrepreneur, and also as a scientist, including leadership of discovery/preclinical development teams resulting in successful drug candidates NUZYRA (omadacycline) and SEYSARA (sarecycline), FDA approved Oct 2018.

    https://www.linkedin.com/in/rogerfrechette/


    FURTHER INFORMATION:

    Location:

    Webinar

    Registration:

    Free Webinar


    • 05 May 2020
    • 7:00 PM - 8:30 PM
    • FREE ONLINE WEBINAR

    ENET is pleased to present this event as a FREE online webinar!  

    Detailed Information for this meeting will be posted when available.





    • 19 May 2020
    • 7:00 PM - 8:30 PM
    • FREE ONLINE WEBINAR

    ENET is pleased to present this event as a FREE online webinar! 

    The registration url will be posted when available.


    Universities are excellent sources of cutting-edge science and technology – the kinds of innovations that can form the basis for important, novel commercial products. One of the ways to commercialize academic assets is through a licensing deal with an established company. However, this is ENET – we’re all about entrepreneurs.

    While academic research often is the source or inspiration for innovative projects and products for start-ups in life sciences and tech fields, the transition from ivory tower to successful product launch comes with a laundry list of challenges.

    Tonight’s panel will offer insights that help to identify and to surmount the challenges, from determining the commercial viability of an idea, to understanding the essential steps on the path to success.

    Panel:

     Roy Wallen, CEO TendoNova Corporation

    Roy Wallen leads TendoNova Corporation, a development-stage medical technology company that is addressing shortcomings in treating chronic tendon pain. He has over 30 years of experience in bringing new medical technologies to market and expanding clinical applications for existing markets. Roy’s broad experience includes work in large, global companies and start-ups, including one IPO, in domestic and international markets.

    https://www.linkedin.com/in/roywallen/

     J. Peter Fasse, Principal at Fish & Richardson P.C.

    Peter Fasse is a Principal in the Boston office of Fish & Richardson, and has been working at Fish since 1987. Peter has two B.S. degrees from MIT, in Life Sciences and Bioelectrical Engineering. His practice emphasizes client counseling, opinion work, and patent prosecution in a wide variety of technologies, with an emphasis on healthcare, medical devices, and other biomedical fields plus various “green” technologies. Peter helps clients from start-ups to multinationals to develop competitive worldwide patent strategies and to establish solid and defensible patent portfolios. He performs competitive patent analyses, identifies third-party patent risks, and provides patentability and freedom-to-operate opinions. Peter also has experience in opposing and defending patents before the European Patent Office and in U.S. litigation and post-grant proceedings. Peter has experience in various fields including medical therapeutics, diagnostics, devices, imaging, microfluidic systems, RNAi and CRISPR therapeutics, dendritic cell- and DNA- based vaccines, liquid biopsy, engineered AAV systems, next generation sequence analysis, cell culturing and bioprocessing, nanoparticle and vector-based delivery, wind and solar power, optics, and lasers.

    https://www.linkedin.com/in/peter-fasse-2207911/

     Sofia Braag-Ankeny, Principal, Office of Business Development and Innovation, University of Massachusetts Medical School

    Sofia is responsible for search and evaluation of new technologies at the university, working with inventors to evaluate, market and partner academic inventions via direct out- licensing opportunities or through company creation. A Swedish native, Sofia joined UMass Medical School in 2007 from University of Florida, into the lab of Dr. Terence Flotte, a pioneer in the field of Gene Therapy, where she co-authored several papers around immunomodulatory gene therapy for Cystic fibrosis and other pulmonary disorders. Sofia also served as the Managing Editor for the Journal Human Gene therapy and Human Gene Therapy Methods for 4 years.

    In 2010 Sofia earned an MBA in management from Assumption College, with a full scholarship from the Marcus Wallenberg Foundation. She then transitioned from the bench into a role helping to establish a new BD office at the Medical school. Sofia holds a M.S. in Medical Biology and a B.S. in Clinical laboratory Medicine, from. Linkoping University, Sweden

    In addition to her role at UMass Medical School she sits on the board of the Swedish American Chamber of Commerce, working to help introduce Swedish businesses into the US market, validate product/market fit and make meaningful business introductions.

    https://www.linkedin.com/in/sofia-braag-mba-ms-529b5520/

    Moderator

     Lucie Rochard, Liaison for Scientific & Entrepreneurial Initiatives, Innovation Services, MassBio

    Lucie joined MassBio in June 2017 as Liaison for Scientific & Entrepreneurial Initiatives, Innovation Services, to strengthen partnership and collaboration with academic institutions and organizations. Prior to joining MassBio, Lucie did her postdoctoral research at MGH, studying craniofacial development, identifying critical molecular pathways for embryonic patterning. Lucie holds a Ph.D. from the University of Rennes, France. Lucie is committed to giving as quickly as possible patients’ access to new medicine by connecting scientists - innovators, from both inside and outside of academia.

    https://www.linkedin.com/in/lucierochard/

    Meeting Organizer

     Roger Frechette, Life Science Business Executive / Entrepreneur / Mentor – NEPAssociates, LLC

    My daily purpose is to exercise an innate drive to transform ideas and projects into life-changing commercial assets. In the life science business, this is the long game, requiring boundless energy and creativity, coupled with knowledge, experience, and patience.

    In my consulting work, I help clients as a business adviser or on-demand, fractional executive. I leverage an extensive global network and insights derived from >20 years of experience in business development, calibrated with an extensive science background. My career has encompassed success as a business executive, project and strategic alliance manager, entrepreneur, and also as a scientist, including leadership of discovery/preclinical development teams resulting in successful drug candidates NUZYRA (omadacycline) and SEYSARA (sarecycline), FDA approved Oct 2018.

    https://www.linkedin.com/in/rogerfrechette/

    • 02 Jun 2020
    • 7:00 PM - 8:30 PM
    • FREE ONLINE WEBINAR

    ENET is pleased to present this event as a FREE online webinar!  

    Detailed Information for this meeting will be posted when available.


    • 16 Jul 2020
    • 6:45 PM - 9:30 PM
    • Rowes Wharf, Boston, MA

    This event has been postponed until July 2021