Veit Schmelmer Email and Phone Number
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Extensive drug product development experience in the pharmaceutical / biotech industry directing R&D and new product development functions. Experienced and successful both as leader of cross-functional global development teams and as line function director. Strong scientific background. Strategic thinker. Diverse cultural background.Specialties: - Leader of global, cross-functional development teams from preclinical and clinical stages through approval/launch and life-cycle management- Small molecule and biologics development experience- Cross-functional evaluation of In-Licensing Opportunities- Alliance management- Portfolio strategy- Change management- Development experience in various therapeutic areas with recent focus in oncology- Solid CMC expertise and experienced leader of CMC line-function- Bridging cultural differences: collaboration with Japan
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Vice President, Program Management And Portfolio StrategyAttovia Therapeutics Nov 2023 - PresentFremont, California, UsDefining a portfolio strategy for Attovia's innovative biologic platform and directing the development of novel therapies targeting a broad spectrum of diseases with high unmet need. -
Senior Vice President, Program And Alliance ManagementVor Biopharma Oct 2021 - Nov 2023Cambridge, Massachusetts, Us- Directing Program and Alliance Management- Providing strategic leadership across the R&D portfolio -
Vice President, Program LeadMagenta Therapeutics Apr 2019 - Sep 2021Cambridge, Massachusetts, Us- Strategic global program responsibility for MGTA-145, a novel biologic for the mobilization of hematopoietic stem cells prior to bone marrow transplant- Leading cross-functional strategic program teams in charge of strategy and execution of Magenta's pipeline programs- Developing and maintaining key strategic documents (target product profile, asset strategy, asset valuation, competitive environment, performance benchmarks) and integrated development plans- Communicating project strategies, scenarios and options to Executive Management Committees to facilitate program decisions and to support the company’s Portfolio Management process -
Vice President, R&D Project Leadership And Portfolio StrategyMersana Therapeutics Sep 2017 - Jan 2019Cambridge, Ma, Us- Head of R&D Project Leadership, Alliance Management and Portfolio Strategy.- Directing the company's program and portfolio activities to ensure scientific and strategic alignment across all platform and pipeline programs, maximize portfolio value, optimize operational execution, drive decision making, and achieve the company’s goals towards developing novel, innovative oncology biotherapeutcs.- Managing research and development alliances with external partners, representing the company on Joint Steering Committees and Joint Development Committees.- Supporting the Chief Business Officer in evaluating licensing and business opportunities. Leading cross-functional licensing evaluation teams.- Supporting the Chief Financial Officer in forecasting and managing the corporate budget.- Managing and mentoring a group of program and alliance managers. -
Senior Director, Drug Development Management & PortfolioTakeda Pharmaceuticals Sep 2006 - Sep 2017Tokyo, Jp- Directed global development of Entyvio®, a novel biologic for the treatment of Crohn’s disease and ulcerative colitis, through Ph3, MAA/BLA review, approval and launch.- As Global Project Leader, responsible for Program and Project Development Strategies for new pipeline projects (small molecules, monoclonal antibodies, antibody-drug conjugates) in inflammation and oncology indications. Strategic program responsibility for the entire life cycle of pipeline projects (from late stage discovery through all phases of pre-clinical/clinical development to post-approval life cycle management).- Oversaw developemnt of Entyvio (vedolizumab: a novel antibody against α4β7 integrin for treatment of Crohn’s disease and ulcerative colitis) through Ph3 development, approval and launch.- Leader of multifunctional (Nonclinical, CMC, Medical, Commercial, Regulatory, Finance, Legal), global product teams for various inflammation and oncology programs (small moleculs and biologics).- Alliance Manager for programs developed under strategic partnership between Millennium/Takeda and 3rd parties.- Supporting in-/out- licensing evaluations and negotiations.- Active involvement in the development of business processes. -
Head, Cmc DevelopmentNippon Boehringer Ingelheim May 2005 - Sep 2006Ingelheim Am Rhein, Rhineland-Palatinate, De- Directed integrated CMC Development unit (formulation and analytical development, scale up facility, clinical supply manufacture); total of 55 staff- Integrated Japanese Development unit into global development processes and organization- Planned new R&D facility -
Associate Director, Project Leader R&DBoehringer Ingelheim Usa Corporation Jul 2001 - May 2005• Led multifunctional (Pharm/Tox, DMPK, CMC, Operations), global R&D Teams for tipranavir (Aptivus®; novel non-peptidic HIV protease inhibitor), BILR 355 (non-nucleoside reverse transcriptase inhibitor), and meloxicam (Mobic®; preferential COX-2 inhibitor).• Directed tipranvir launch preparation and post-marketing activities (e.g., line extensions, 2nd generation products).• Represented R&D as global Core Team Member R&D on international development teams.• Developed, implemented, executed and tracked development plans on a local and international level.• R&D interface to regulatory agencies (e.g., FDA, EMEA, etc.).• Led Evaluation Teams for in-depth evaluation of in-licensing projects (all phases of clinical development) and coordinated due diligence activities.• Led transition of new development candidates from Discovery to Development.• Member of various global Corporate Strategy initiatives.
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Associate Director, Project Leader R&DBoehringer Ingelheim Pharma Gmbh & Co. Kg Mar 2000 - Jun 2001• Led multifunctional, global R&D Teams for BIBR1048 MS (INN: dabigatran) and BIBR 953 ZW (both direct thrombin inhibitors), BIBT 986 BS and BIBT 1011 BS (both combined thrombin / factor Xa inhibitors), Aggrenox® (dipyridamole + ASS; inhibitor of cellular adenosine uptake), and meloxicam (preferential COX-2 inhibitor).• Developed Target Product Profile (TPP), Product Development Plan (PDP) for various cardiovascular projects.• Implemented the Development Strategy for development compounds by establishing and leading international Core Teams (pre-development to release of phase I) and R&D Teams (pre-development to launch).• Prepared IBs and INDs/CTAAs.• Ensured seamless transfer of new projects from Discovery to Development.• Led preparation of all Non-clinical (Pharm/Tox, DMPK), CMC and Operations documentation for U.S. NDA for meloxicam (Mobic® / Metacam®; preferential COX-2 inhibitor) tablets and veterinary suspension. Directed all related review activities.
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Senior Principle Scientist, Drug Discovery Support And New Technology, Pharmaceutics DepartmentBoehringer Ingelheim Pharma Gmbh & Co. Kg Aug 1998 - Feb 2000• Integration of new technologies (delivery systems, non-conventional oral dosage forms).• Liaison for proprietary technology licensing and technology evaluations.• Responsible for the support of Research disciplines during the late drug discovery phase (lead optimization, candidate selection).• Development of experimental formulations in support of early animal experiments. Implemented strategies and technologies to develop formulations on a micro scale to account for limited substance supply during drug discovery phase.• Assessment of phys.-chem. properties of research compounds with respect to their potential impact on drug product development and biopharmaceutical profile.• Implementation of organizational structures at the interface between research and development.
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Senior Scientist, Formulation Development And Process Research, Pharmaceutics DepartmentBoehringer Ingelheim Pharma Gmbh & Co. Kg Jan 1996 - Jul 1998• Development of non-solid dosage forms (oral and nasal liquids, topical dosage forms; delivery systems for poorly soluble drugs) for human and veterinary use.• Process development and scale up for non-solid dosage forms (incl. bulk manufacture for clinical supplies) from lab scale to full production scale.• Technology transfer (non-solid dosage forms) from R&D sites to productions sites in Europe and the United States.• Development of pre-clinical trial formulations (incl. supply manufacture for GLP studies in animals).• Acted as Team Member Pharmaceutics on international R&D Teams in BI’s global matrix structure. Responsible for all formulation related aspects for projects in all clinical phases.
Veit Schmelmer Skills
Veit Schmelmer Education Details
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Heidelberg UniversityDoctor Of Philosophy - Phd
Frequently Asked Questions about Veit Schmelmer
What company does Veit Schmelmer work for?
Veit Schmelmer works for Attovia Therapeutics
What is Veit Schmelmer's role at the current company?
Veit Schmelmer's current role is Vice President, Program Management and Portfolio Strategy.
What is Veit Schmelmer's email address?
Veit Schmelmer's email address is ve****@****eda.com
What is Veit Schmelmer's direct phone number?
Veit Schmelmer's direct phone number is .224.554*****
What schools did Veit Schmelmer attend?
Veit Schmelmer attended Heidelberg University.
What skills is Veit Schmelmer known for?
Veit Schmelmer has skills like Drug Development, Clinical Development, Pharmaceutical Industry, Drug Discovery, Biotechnology, Oncology, Biopharmaceuticals, Pharmaceutics, R&d, Clinical Trials, Regulatory Submissions, Life Sciences.
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