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

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

    Please register here: https://bit.ly/ENET2916w


    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

    Register here: https://bit.ly/ENET2916w

    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:

    Free Online Webinar: 

    Register here: https://bit.ly/ENET2916w



    • 05 May 2020
    • 7:00 PM - 8:45 PM
    • FREE ONLINE WEBINAR

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

    Sustaining Your Early Stage Life Science Company during the COVID-19 Pandemic crisis

    ENET and MDG (The Medical Development Group) are pleased to present a Joint Webinar addressing the most profound medical development of recent memory. 

    Use this link to pre-register:  https://bit.ly/ENET2917w

    (Please note capacity is limited so pre-registration is necessary) 

    We are living through a medical pandemic that dwarfs any medical issue of the past 100 years.  Not only does it threaten the health of every American, it threatens the economic foundation of our society, and that of the entire world.  There is no greater priority than preserving our lives and our way of life.  For the joint membership of ENET and MDG, that means sustaining our businesses during this financial and medical crisis.  This webinar gathers outstanding thought leaders whose positions have brought the issues raised by current events into especially sharp focus.  They will outline their thoughts and be available for questions and discussion. 

    On May 5, from 7 TO 8:45 pm EST, ENET and MDG will present this critically important webinar, addressing existential problems facing early stage medical start-up companies in this financial melt-down.  We will consider the question: In order to enhance your company’s survivability, what are the choices you must make to live and fight another day?  Our panel consists of two serial entrepreneurs, one specializing in medical devices, the other in biotech; three attorneys, one who heads his firm’s COVID-19 task force, a second who focuses on representing the needs of early stage medical companies and the third whose expertise is in Federal support being offered under recent Federal Legislation and response.  Our moderator is ENET’s chair emeritus who has published two articles on COVID-19 work force reduction and maximizing unemployment benefits for employees laid off or reduced in hours. 

    The webinar is free.

    Agenda: 

    7:00 - 7:10 PM - ENET Chairperson's announcements

    7:10 - 7:15 PM – MDG President’s announcements

    7:15 - 7:25 PM – eMinute Pitch  - Up to 2 Startup companies’ presentations

    7:25 - 8:25 PM - 5 expert speakers on the night's topic

    8:25 - 8:45 PM – Audience Q and A to the speakers

    (all times are USA Eastern Daylight time)

    Register Here: https://bit.ly/ENET2917w

    Speakers: 

    Dr. Amar Sawhney, CEO of Instylla, Inc.

    Dr. Sawhney has founded six companies, which account for over 1,600 jobs created and over $1.5 billion in revenue to date. He helps foster entrepreneurship by mentoring young innovators and creating companies through Incept, a medical device incubator.

    His company, Instylla, focused on embolic therapies for hypervascular tumors and control of hemorrhage. He was previously the Founder and CEO of Ocular Therapeutix, Augmenix, Confluent Surgical, and the technology founder of Focal and Access Closure.  Dr. Sawhney’s innovations are the subject of over 120 issued and pending patents in biomaterials and bio-surgery.  His inventions include several “first of a kind” surgical sealants and spacers to be approved by the FDA including ReSure Sealant for ophthalmology, DuraSeal for neurosurgery, FocalSeal for Lung surgery, Mynx for femoral puncture sealing, and SpaceOAR for prostate cancer radiotherapy. Amar and his partner Fred Khosravi, have also created Incept LLC, which provides a platform to support other healthcare entrepreneurs. 

    Dr. Sawhney has been recognized by several awards including being named the “Champion of Change” by the Whitehouse and “Outstanding American by Choice” by the US Citizenship and Immigration Service, Dr. Sawhney’s companies and inventions have touched over 5 million patients and have created over 2000 jobs to date.

    Dr. Sawhney holds an M.S. and a Ph.D. in Chemical Engineering from the University of Texas at Austin and a B. Tech. in Chemical Engineering from the Indian Institute of Technology, New Delhi.

    https://www.linkedin.com/in/amar-sawhney-a4b143/

    Colin J. Zick,  partner with Foley Hoag LLP, Co-Chair of the firm’s Data Privacy & Security and Healthcare practice groups, and its COVID-19 Task Force. 

    His law practice is focused on health care and compliance issues, and often involves the intersection of those two subjects in investigations, administrative proceedings or litigation. His work has a particular emphasis on compliance issues related to life sciences, pharmaceutical and medical device companies, laboratories, and provider organizations. This compliance work includes helping clients establish and maintain effective compliance programs. He counsels clients ranging from the Fortune 1000 to start-ups on issues involving information privacy and security, including compliance with state, federal and international data privacy and security laws and government enforcement actions (including GDPR and EU-US Privacy Shield, CCPA, HIPAA and other U.S. federal and state data privacy and security laws, privacy policies, cloud security, cyber insurance, the Internet of Things, and data breach response). Colin also defends clients in disputes alleging kickbacks, overpayments, and billing and coding problems.  Colin is ranked as one of the Best Lawyers in America® for Healthcare and for Privacy and Data Security Law, ranked by CHAMBERS USA as one of Massachusetts' leading health care lawyers since 2010, and he has been selected by his peers as a Massachusetts “Super Lawyer” since 2004. 

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

    Benjamin M. Hron, Partner and Business Attorney, McCarter & English, LLP.

    Ben’s law practice focuses on representing companies on general corporate matters, debt and equity financing, mergers and acquisitions, securities law compliance and joint ventures. Ben also represents private equity and venture capital funds, angel investors and financial institutions in connection with the financing of public and private companies.  Ben serves as outside general counsel for a number of his clients, advising company management on legal issues ranging from day-to-day matters to large strategic initiatives. He also coordinates and supervises the work of experts in other practice areas when appropriate. In addition to working with established companies, Ben has extensive experience working with entrepreneurs and startups, often getting involved when a business is still in its infancy and helping guide the founders through the formative early stages of their company’s development. The experience of co-founding and growing his own law firm, VC Ready Law Group, which he ran from 2009 to 2011 prior to joining McCarter, has helped Ben better understand and address the issues facing many of his clients.  Ben was co-chair of the Securities Law Committee of the Boston Bar Association from 2013 to 2015 and co-chair of the BBA’s Venture Capital and Emerging Companies Committee from 2015 to 2017.  From 2011 to 2017 he hosted a McCarter & English seminar series for entrepreneurs at the Cambridge Innovation Center.  Ben is a graduate of Harvard Law School.

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

    Leslie J. Williams, Entrepreneur, Executive, Board Member, Mentor: Former Founder, President & CEO ImmusanT; BoD at Ocular Therapeutix

    Ms. Williams has more than 25 years of industry experience in healthcare, management, commercial product development and marketing. In 2010 she founded ImmusanT, Inc., which subsequently acquired the assets of Melbourne, Australia based Nexpep.  ImmusanT completed a reference merger post Phase 2b in December, 2019.  Prior to founding ImmusanT, she was President & CEO of Ventaira Pharmaceuticals, a significant player in the pulmonary drug delivery market. Ms. Williams’ prior pharmaceutical industry experience includes commercial positions at INO Therapeutics, Merck and GlaxoSmithKline, and drug-delivery and -monitoring experience at Datex-Ohmeda (formerly Ohmeda, Inc.). She was a venture partner at Battelle Ventures and serves on the Board of Ocular Therapeutix, Inc (NASDAQ: OCUL) and served on the Boards of Hepregen Corporation, CDI Bioscience, and on the Board of The Capital Network (TCN). She currently serves on the Advisory Board of Life Science Cares and is on the Executive Board of the University of Iowa School of Pharmacy. She also serves on the Editorial Advisory Board of Life Science Leader as well as The Journal of Advanced Therapies and Medical Innovation Sciences. Ms. Williams holds an MBA from Washington University, John Olin School of Business, and a BS degree with honors in nursing from the University of Iowa. Before entering industry, she was a critical-care nurse at Duke University, Medical College of Virginia and at the University of Iowa.

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

    Aaron T. Kriss, Partner and Tax Attorney, Gesmer Updegrove LLP

    Aaron handles all things tax, heading the firm’s tax group and supporting the firm’s other practice groups. Aaron spends much of his time helping clients structure their organizations, develop equity compensation plans, navigate complex tax rules pertaining to mergers and acquisitions and IP-related issues, and understand the federal, state, and international tax implications of various transactions. Aaron also focuses on state and local tax audits, federal tax controversies, the tax aspects of real estate transactions, and tax issues pertaining to fund formation and administration. He approaches all tax-related questions from a business and “common-sense” perspective, opting for the most simple and efficient solution that fits a clients’ business goals rather than an overly complicated plan that, while tax efficient in the short-run, may cause more business headaches down the road.   Prior to joining Gesmer Updegrove, Aaron has worked as an attorney at Day Pitney LLP and Withers Bergman LLP, focusing primarily on tax issues relating to private companies and high-net worth individuals and entrepreneurs. Aaron is a graduate of University of Virginia Law School.

    https://www.linkedin.com/in/aaron-kriss-9b112059/

    Co-Organizer and Moderator:

    Robert A. Adelson, Principal, Business and Tax attorney, Adelson & Associates, LLC. Chair Emeritus, Boston Entrepreneurs’ Network (ENET). 

    Rob has been an attorney for over 30 years specialized in business, tax, stock and options, employment, contracts, financing, trademarks and intellectual property.  Rob began as an associate at major New York City law firms before returning home to Boston in 1985 where he has since been a partner in small and medium sized firms before joining Engel & Schultz LLP where he was a partner from 2004 to 2019. When the senior partners retired, he moved his law practice to his own firm. Rob represents entrepreneurs, start-ups and small companies, independent contractors and employees and executives. Rob is a frequent speaker on business law topics and author of numerous articles published in Boston Business Journal, Mass High Tech and other publications, plus more than twenty articles since 2016 on executive employment topics published by CEOWorld magazine. He has been named among the “Top 20 Boston Startup Lawyers” by ChubbyBrain.com, a website that provides tools for entrepreneurs. Rob has been on the ENET Board since 2002, was Vice Chair 2005-2009, and ENET Chairman 2009-2019.  He was also a Co-Founder and Board member of the 128 Innovation Capital Group (2004 -2015). In 2016, he received the IEEE USA Professional Achievement award for “extreme dedication to the entrepreneurship community.” He holds degrees from Boston University, B.A., summa cum laude, Northwestern University (Chicago), J.D., Law Review, and New York University, LL.M. in Taxation. 

    https://www.linkedin.com/in/robert-adelson-b8a1557/

    Co-Organizer:

    Peter N. Madras, M.D., Lecturer, Institute for Medical Eng and Science, MIT, President, Medical Development Group of Boston (MDG)

    Dr. Madras, a graduate of McGill Medical School is a retired transplant and vascular surgeon and Associate Prof. at Harvard Medical School, a founder of two companies and board member of a number of start-ups. He is currently lecturer in the Institute for Medical Engineering and Science at MIT and President of the Medical Development Group (MDG).  During his practice, Dr. Madras was member and Chairman of the Massachusetts Board of Registration in Medicine.  He served for ten years as Medical Director for Grace Biomedical in the development of a liver support system and an artificial pancreas. He has authored 80 papers and holds 3 patents.  Prior to his surgical career, Peter was Director of the Medical Group at Avco Everett Research laboratory which brought to market the first mechanical cardiac assist device, the intra-aortic balloon.  This group was spun off to form five different medical companies, the largest of which is Abiomed.

    https://www.linkedin.com/in/peter-n-madras-m-d-0187421/

    Register Here: https://bit.ly/ENET2917w

    • 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