BEGIN:VCALENDAR VERSION:2.0 PRODID:-//BioNJ - ECPv6.15.20//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-ORIGINAL-URL:https://bionj.org X-WR-CALDESC:Events for BioNJ REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20230312T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20231105T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20240310T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20241103T060000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20250309T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20251102T060000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/New_York:20241010T073000 DTEND;TZID=America/New_York:20241010T163000 DTSTAMP:20260503T032446 CREATED:20240318T181526Z LAST-MODIFIED:20241002T120610Z UID:11216-1728545400-1728577800@bionj.org SUMMARY:2024 BioNJ C-Suite Summit DESCRIPTION:THIS EVENT IS CLOSED TO THE MEDIA \n\n\n\nAn Inflection Point for Innovation in Life Sciences\n\n\n\nThursday\, October 10\, 2024 | 7:30 a.m.-4:30 p.m. Bridgewater Marriott\, 700 Commons Way\, Bridgewater\, NJ \n\n\n\n\nRegister Today\n\n\n\nBecome a Sponsor\n\n\n\n\nAgainst a backdrop of change\, the biopharmaceutical industry – and the next wave of innovation – are at an inflection point. Join us to reflect on the state of innovation in life sciences and how companies can best navigate through this period of continued change. \n\n\n\n \n \n \n \n \n \n\n TimeAGENDA\n\n\n\n \n 7:30 a.m. – 8:15 a.m.Registration & Networking Breakfast \n \n \n8:15 a.m. – 8:20 a.m.\n\n Welcome & Opening Remarks \n\nDebbie Hart\, President & CEO\, BioNJ\nEmer Leahy\, MBA\, Ph.D.\, President & CEO\, PsychoGenics & Chair\, BioNJ\n\n\n \n \n \n \n \n \n\n\n\n\n\n \n \n \n \n \n \n\n TimeINNOVATION\n\n\n\n \n \n8:20 a.m. – 8:50 a.m.\n\nKeynote: The Next Wave of Innovation in Life Sciences \nLife sciences leaders are navigating a period of exciting innovation. Novel modalities and mechanisms of action have helped the industry address previously stubborn unmet needs. Over the past 10 years\, R&D spend has increased\, the pipeline has become more diverse and new asset approvals have accelerated. Looking ahead\, policy reforms (e.g.\, IRA)\, a rapid proliferation in technological resources (e.g.\, AI\, mRNA platforms) and a rise in cross-company collaborations suggest further change and opportunity. Join us in reflecting on what the future of life sciences innovation holds\, and implications for large cap pharma companies\, biotechs and life sciences investors.  \n\nBrandon Parry\, MBA\, Sr. Partner\, McKinsey & Company\n\n \n \n \n8:50 a.m. – 9:45 a.m.\n\nPanel: Harnessing Change to Deliver Impactful Innovation \nIndustry leaders will reflect on the state of innovation\, expected industry shifts\, latest thinking on development paradigms\, portfolio shifts\, the lasting implications of policy reforms\, the impact of technological evolutions\, talent priorities and more. \n\nGarrett Ingram\, President & CEO\, Cipla Therapeutics\nWill Lewis\, MBA\, J.D.\, Chair & CEO\, Insmed\nClive Meanwell\, M.D.\, Chair & Partner\, Population Health Partners\nTarek Rabah\, MBA\, President & CEO\, Otsuka Pharmaceuticals\nScott White\, MBA\, Chief Operations Officer\, NA Innovative Medicine\, Johnson & Johnson\nConversation Leader: Harriet Keane\, Ph.D.\, Partner\, McKinsey & Company\n\n \n \n \n \n \n \n\n\n\n\n\n \n \n \n \n \n \n\n TimePOLICY\n\n\n\n \n \n9:45 a.m. – 10:15 a.m.\n\nFireside Chat: Policy Uncertainties in an Election Year \nThe past 18 months have borne witness to a rapidly evolving policy landscape (including but not limited to the IRA\, IP\, BIOSECURE) – with expected evolutions on the horizon compounded by a tumultuous election season. With the presidential election just a few weeks away\, this session will explore potential health policy changes and implications for industry leaders. \n\nHon. Jim Greenwood\, Former Congressman & Former President & CEO\, BIO \nHeather Meade\, Principal\, EY\nConversation Leader: Lisa LeCointe-Cephas\, J.D.\, Partner\, Compliance & Investigations & Global Chair\, Life Sciences Sector\, DLA Piper\n\n \n \n 10:15 a.m. – 10:30 a.m.\nNetworking Break \n \n \n \n \n \n \n\n\n\n\n\n \n \n \n \n \n \n\n TimeMARKET ACCESS\n\n\n\n \n 10:30 a.m. – 11:15 a.m.\nPanel: Market Access & ReimbursementThe market access landscape is intricate and constantly evolving\, with payers persistently refining their business models and strategies. This panel will explore the essential groundwork for securing optimal reimbursement and payer coverage\, which are crucial for ensuring Patient access to treatments and\, ultimately\, improving Patient care. The panel will also address key issues manufacturers face including changing legislation\, consolidation\, M&A\, gross to net and commercial launch planning. \n\nPaul Hunter\, Vice President\, Market Access and Commercial Operations\, Halozyme\nChristopher Jackson\, J.D.\, Managing Member\, The Law Office of Christopher S. Jackson\nJake McDowell\, Vice President\, Head\, Market Access\, Pricing and Value\, Partner Therapeutics\nConversation Leader: Tom Evegan\, Principal\, Strategy & Management Consulting; National Consulting Leader Life Sciences\, RSM\n\n \n \n \n \n \n \n\n\n\n\n\n \n \n \n \n \n \n\n TimeTALENT\n\n\n\n \n 11:15 a.m. – 12:00 p.m.\nPanel: Topics in Talent: Attraction\, Retention & DiversityIn the life sciences sector\, talent development is crucial for fostering innovation and addressing complex challenges. Companies are focused on developing the next generation of talent by providing opportunities for education\, training and mentorship. Additionally\, there is a growing emphasis on upskilling and reskilling talent to leverage AI and other advanced technologies for greater efficiency and effectiveness. This discussion will explore key learnings from workplace evolutions and strategies companies can and must adopt such as equity. \n\nBritt Byers\, Executive Vice President\, Human Resources NA\, Kyowa Kirin\nVikki Conway\, Sr. Vice President & Head\, Human Resources\, U.S.\, Teva Pharmaceuticals\nKiran Dattani\, MPH\, MBA\, Customer Success\, Transformation\, Strategy & Architecture\, Google Cloud Healthcare & Life Sciences\, Google\nConversation Leader: Jan Campbell\, Managing Partner Pharmaceuticals & Biotechnology\, Korn Ferry\n\n \n \n \n \n \n \n\n\n\n\n\n \n \n \n \n \n \n\n TimeRESEARCH & DEVELOPMENT\n\n\n\n \n 12:00 p.m. – 12:30 p.m.\nFireside Chat: Research & Development in Mental HealthWith Global Mental Health Day as the backdrop\, this discussion features two pioneers in mental health research and development and will explore the challenges in developing therapeutics in the mental health space and how they can provide learnings in other areas. \n\nHusseini Manji\, M.D.\, F.R.C.P.C.\, Professor\, Oxford University; Co-Chair\, UK Govt MH Mission; Former Global Head\, Neuroscience\, Janssen/Johnson & Johnson\nConversation Leader: Emer Leahy\, MBA\, Ph.D.\, President & CEO\, PsychoGenics & Chair\, BioNJ\n\n \n \n 12:30 p.m. – 1:30 p.m.\nNetworking Lunch \n \n \n \n \n \n \n\n\n\n\n\n \n \n \n \n \n \n\n TimeCOMMERCIALIZATION & PATIENT SERVICES\n\n\n\n \n 1:30 p.m. – 2:15 p.m.\nPanel: Continued Evolutions in Go-to-Market Models Including Patient ServicesThe continued evolution of the go-to-market (GTM) commercial model in life sciences has been characterized by a shift from push to pull strategies\, the development of novel roles that rethink traditional functional boundaries in a compliant manner\, and a simplification of the customer interface. This talk will explore how these approaches can enhance and improve Patient access to treatments given the complex journey that is the Patient experience. Getting it right can have a major impact on Patient outcomes\, as Patient experience in healthcare continues to lag. personalized journeys. \n\nJohn Harlow\, Chief Commercial Officer\, Melinta Therapeutics\nRohan Jain\, General Manager\, Commercial\, Nusano\nGina Murdoch\, MBA\, President & CEO\, Multiple Sclerosis Association of America\nConversation Leader: Haripriya Jain\, MS\, MBA\, Executive Director\, Global Value & Access Consulting\,  Evidera\, part of Thermo Fisher Scientific \n\n \n \n \n \n \n \n\n\n\n\n\n \n \n \n \n \n \n\n TimeCAPITAL MARKETS\n\n\n\n \n 2:15 p.m. – 3:00 p.m.\nPanel: Evolving Capital Markets & Implications for InnovationThe life sciences industry market cap has more than tripled in a decade despite more recent challenges. This discussion will explore the latest funding environment (e.g.\, IPOs) and implications for industry. \n\nAamir Mecklai\, Managing Director\, Healthcare Investment Banking\, Bank of America\nChristopher Mortko\,MBA\, Ph.D.\, Vice President\, Business Development & Licensing\, Merck & Co.\nMonika Vnuk\, M.D.\, Sr. Vice President\, Global Partnering & Business Development\, Sanofi\nConversation Leader: Arda Ural\, MBA\, Ph.D.\, Americas Life Sciences Sector Leader\, EY\n\n \n \n \n \n \n \n\n\n\n\n\n \n \n \n \n \n \n\n TimeAI & TECHNOLOGY\n\n\n\n \n 3:00 p.m. – 3:45 p.m.\nPanel: The Digital & AI Era in the Biopharma Industry: How Can Companies Across Functions Transition from Hype Into Reality?In the current environment\, the biopharmaceutical industry is experiencing a transformative shift towards digitalization and AI adoption\, promising improved efficiency\, innovation and Patient outcomes. However\, for companies to transition successfully from the hype surrounding these technologies into tangible benefits\, they must integrate digital and AI solutions across functions\, prioritize data-driven decision-making and foster a culture of innovation and adaptability. \n\nSydney Klein\, Chief Information Security Officer & Head of IT Core Services\, Bristol Myers Squibb\nHisham Hamadeh\, Ph.D.\, Sr. Vice President & Global Head\, Data Science & AI\, Genmab\nKeith Koharski\, MBA\, Executive Director\, Global Development IT\, Regeneron\nDeiva Ramachandran\, Ph.D.\, Partner\, Generative AI-Automation Practice Leader\, Healthcare\, Life Sciences\, State & Local Government\, IBM\nConversation Leader: Donna Conroy\, Founder\, CEO\, SciMar ONE\n\n \n \n \n \n \n \n\n\n\n\n\n \n \n \n \n \n \n \n \n \n\n\n\n\n\nJoin us on October 10 for this important conversation. Registration is $695 for BioNJ Members and $895 for Future Members. (BioNJ is pleased to have maintained our pricing unchanged for the past three years.) Click here to register. \n\n\n\nThank You to Our Sponsors URL:https://bionj.org/event/2024-bionj-c-suite-summit/ LOCATION:New Jersey CATEGORIES:BioNJ Event ATTACH;FMTTYPE=image/png:https://bionj.org/wp-content/uploads/2024/03/CSuite-Summit-2024.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20241022T120000 DTEND;TZID=America/New_York:20241022T130000 DTSTAMP:20260503T032446 CREATED:20240926T131152Z LAST-MODIFIED:20240926T131327Z UID:12772-1729598400-1729602000@bionj.org SUMMARY:Positioning Early Cell Therapy for Clinical Success: Mitigating Risk & Ensuring GMP Readiness DESCRIPTION:Positioning Early Cell Therapy for Clinical Success: Mitigating Risk & Ensuring GMP Readiness\n\n\n\nTuesday\, October 22\, 2024 | 12:00 p.m.-1:00 p.m. | Virtual \n\n\n\n\nREGISTER TODAY FOR FREE!\n\n\n\n\nThe promise of cell therapies is often tempered by the many complexities of transitioning these innovations from R&D to the clinic. For early phase programs\, there are many aspects to consider\, from understanding evolving regulatory guidelines and reviewimg pathway options to addressing common manufacturing-related issues such as scalability\, high cost of goods\, and workforce retention. Additionally\, organizing and executing a successful cell therapy clinical trial can be challenged by a limited number of qualified clinical sites with experience in conducting advanced therapy studies\, access to desired Patient populations\, and managing the complex supply chain required to deliver therapies to Patients in a timely fashion. \n\n\n\nThrough a series of brief presentations on three key topic areas\, this webinar will help early phase cell therapy developers identify insights to mitigate risk and ensure clinical readiness to position their programs for success. \n\n\n\nSpecific topic areas of focus include: \n\n\n\n\nNavigating an evolving cell therapy regulatory landscape\n\n\n\nHow to assess GMP-readiness and prepare your cell therapy workflow for clinical and commercial manufacturing\n\n\n\nEnsuring patient-centricity in the complex cell therapy ecosystem and leveraging a unique\, comprehensive operating model for your product\n\n\n\n\nLearning objectives: \n\n\n\n\nStrategies to navigate regulatory hurdles and maximize impact of meetings with regulators\n\n\n\nBest practices to address common challenges in cell therapy process development and manufacturing\n\n\n\nOpportunities for a more streamlined\, Patient-centric approach to cell therapy clinical trials\n\n\n\nBenefits of working with an integrated CRO/CDMO partner to simplify the cell therapy value chain and improve Patient-centricity\n\n\n\n\nPresenters: \n\n\n\n\nMichele DugganSr. Manager\, Regulatory AffairsThermo Fisher Scientific  \n\n\n\nMs. Duggan joined Thermo Fisher Scientific in 2021 as Sr. Manager Regulatory Affairs supporting the development and delivery of regulatory solutions for customers within the biologics and advanced therapies pharma services manufacturing network. Prior to joining Thermo Fisher Scientific\, she spent over 17 years in CMC regulatory consulting\, providing regulatory strategy\, dossier authoring and review expertise for biologics and cell therapy products across all stages of the product life cycle. \n\n\n\n\n\n\n\n\n\nMindy Sadik\, Ph.D.Director\, Cell Therapy SciencesThermo Fisher Scientific  \n\n\n\nDr. Sadik oversees the Process Development and Analytical Development teams for the Cell Therapy Business unit for Advanced Therapies. Dr. Sadik’s teams work closely with partners to provide development and clinical scale services\, which include gene and non-gene modified cell processing for autologous and allogeneic cell therapies. This work includes technology transfer from the client to Thermo Fisher’s site\, process optimization and workflow readiness for transition into GMP manufacturing.  \n\n\n\n\n\n\n\n\n\nKim Watanabe\, Ph.D.Executive Director\, Cell and Gene Therapy Pillar HeadThermo Fisher Scientific  \n\n\n\nDr. Watanabe recently joined PPD\, part of Thermo Fisher Scientific\, where she leads business and operational strategy development and deployment in hematology and oncology clinical development services. She has 20 years of experience in R&D\, business and operations\, of which the last 14 years have been focused on cell and gene therapies. Prior to her current role\, Dr. Watanabe served as General Manager and Site Head for the Patheon Translational Services. Prior to her current role\, she served as GM/ Site Head for the Patheon Translational Services\, part of the contract development and manufacturing organization of Thermo Fisher Scientific. \n\n\n\n\n\n\n\n\nRegister today and join us on October 22 for this FREE educational webinar. Come ready to learn and ask questions! URL:https://bionj.org/event/positioning-early-cell-therapy-for-clinical-success-mitigating-risk-ensuring-gmp-readiness/ LOCATION:New Jersey END:VEVENT BEGIN:VEVENT DTSTART;TZID=America/New_York:20241024T170000 DTEND;TZID=America/New_York:20241024T190000 DTSTAMP:20260503T032446 CREATED:20241007T140338Z LAST-MODIFIED:20241023T114810Z UID:12860-1729789200-1729796400@bionj.org SUMMARY:Life Sciences Alternative Funding Panel DESCRIPTION:Join us at the New Jersey Bioscience Center for insights into alternative sources of funding to advance life sciences companies in New Jersey. \n\n\n\nThis panel discussion will focus on securing funding from non-traditional sources\, and will address the following questions: \n\n\n\n\nHow will the next generation of drugs\, diagnostics\, and devices be funded?\n\n\n\nWhat new models are there that might change the paradigm?\n\n\n\nIs there a better way to fund early and emerging commercial biomedical research?\n\n\n\n\nPanelists Include: \n\n\n\n\nJosh Barer\, Managing Director at Hibiscus BioVentures\n\n\n\nJudith Sheft\, Executive Director\, NJ CSIT\n\n\n\nJorge Ramirez\, Vice President\, M&A and Business Development\, Quest Diagnostics\n\n\n\n\nModerated by John Pennett\, Partner\, Life Sciences and Technology Group\, Eisner Advisory Group LLC URL:https://bionj.org/event/life-sciences-alternative-funding-panel/ LOCATION:New Jersey CATEGORIES:Industry Event END:VEVENT END:VCALENDAR