An Extension Study Evaluating Long Term Safety and Activity of AGT-181 in Patients With Mucopolysaccharidosis I Who Were Previously Enrolled in Studies With AGT-181

AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously.
This is a long term safety and tolerability study of AGT-181 in patients with MPS I who completed the previous 26-week study, AGT-181-101. Information on the biological activity of the investigational drug will also be collected.

开始日期2016-10-01

申办/合作机构

ArmaGen, Inc.

NCT02597114 / Completed临床1期

An Extension Study of AGT-181-102 Evaluating Safety and Glycosaminoglycans (GAGs) in Adult Patients With Hurler-Scheie or Scheie Syndrome Who Have Completed 8-Weeks of Dosing With AGT-181 in Study AGT-181-102

AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is an extension of a safety and dose ranging study to obtain long term safety and exposure data, as well as information on the biological activity of the investigational drug

开始日期2015-11-01

申办/合作机构

ArmaGen, Inc.

NCT03053089 / Completed临床1/2期

A Two-Stage, Phase 1/2, Open-Label Study of the Human Insulin Receptor Monoclonal Antibody-Human Alpha-L-iduronidase (HIRMAb-IDUA) Fusion Protein, AGT-181 in Patients With Mucopolysaccharidosis I (MPS I, Hurler Syndrome)

AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This is a safety and tolerability study to obtain safety and exposure data as well as information on the biological activity of the investigational drug.
This is a two-stage, sequential, single and multi-dose study of AGT-181 in patients with MPS I. The first stage will be an open-label, single-dose, dose-escalation cohort study and the second stage will be an open-label, multi dose, adaptive dose escalation cohort study.

开始日期2015-10-01

申办/合作机构

ArmaGen, Inc.

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项与 ArmaGen, Inc. 相关的文献（医药）

2018-12-01·Orphanet Journal of Rare Diseases2区 · 医学

Neurocognitive and somatic stabilization in pediatric patients with severe Mucopolysaccharidosis Type I after 52 weeks of intravenous brain-penetrating insulin receptor antibody-iduronidase fusion protein (valanafusp alpha): an open label phase 1-2 trial

2区 · 医学

ArticleOA

作者: Nguyen, Carol ; Schmidt, Mathias ; Boado, Ruben J ; Giugliani, Luciana ; Donis, Karina Carvalho ; Giugliani, Roberto ; Pardridge, William M ; Corte, Amauri Dalla ; de Oliveira Poswar, Fabiano ; Nestrasil, Igor ; Chen, Steven

BACKGROUNDMucopolysaccharidosis (MPS) Type I (MPSI) is caused by mutations in the gene encoding the lysosomal enzyme, α-L-iduronidase (IDUA), and a majority of patients present with severe neurodegeneration and cognitive impairment. Recombinant IDUA does not cross the blood-brain barrier (BBB). To enable BBB transport, IDUA was re-engineered as an IgG-IDUA fusion protein, valanafusp alpha, where the IgG domain targets the BBB human insulin receptor to enable transport of the enzyme into the brain. We report the results of a 52-week clinical trial on the safety and efficacy of valanafusp alpha in pediatric MPSI patients with cognitive impairment. In the phase I trial, 6 adults with attenuated MPSI were administered 0.3, 1, and 3 mg/kg doses of valanafusp alpha by intravenous (IV) infusion. In the phase II trial, 11 pediatric subjects, 2-15 years of age, were treated for 52 weeks with weekly IV infusions of valanafusp alpha at 1, 3, or 6 mg/kg. Assessments of adverse events, cognitive stabilization, and somatic stabilization were made. Outcomes at 52 weeks were compared to baseline.RESULTSDrug related adverse events included infusion related reactions, with an incidence of 1.7%, and transient hypoglycemia, with an incidence of 6.4%. The pediatric subjects had CNS involvement with a mean enrollment Development Quotient (DQ) of 36.1±7.1. The DQ, and the cortical grey matter volume of brain, were stabilized by valanafusp alpha treatment. Somatic manifestations were stabilized, or improved, based on urinary glycosaminoglycan levels, hepatic and spleen volumes, and shoulder range of motion.CONCLUSIONClinical evidence of the cognitive and somatic stabilization indicates that valanafusp alpha is transported into both the CNS and into peripheral organs due to its dual targeting mechanism via the insulin receptor and the mannose 6-phosphate receptor. This novel fusion protein offers a pharmacologic approach to the stabilization of cognitive function in MPSI.TRIAL REGISTRATIONClinical Trials.Gov, NCT03053089 . Retrospectively registered 9 February, 2017; Clinical Trials.Gov, NCT03071341 . Registered 6 March, 2017.

2018-04-01·BioDrugs3区 · 医学

Plasma Pharmacokinetics of Valanafusp Alpha, a Human Insulin Receptor Antibody-Iduronidase Fusion Protein, in Patients with Mucopolysaccharidosis Type I

3区 · 医学

Article

作者: Schmidt, Mathias ; Giugliani, Roberto ; Pardridge, William M ; Boado, Ruben J

BACKGROUNDMucopolysaccharidosis type I (MPSI) is caused by mutations in the gene encoding the α-L-iduronidase (IDUA) lysosomal enzyme and the majority of MPSI patients have severe central nervous system (CNS) involvement. Enzyme replacement therapy (ERT) with recombinant IDUA does not treat the CNS, due to the lack of transport of the enzyme across the blood-brain barrier (BBB). Human IDUA has been re-engineered as an IgG-IDUA fusion protein, valanafusp alpha, where the IgG domain is a monoclonal antibody (MAb) against the human insulin receptor (HIR). The HIRMAb domain binds the endogenous insulin receptor on the human BBB to trigger receptor-mediated transport across the BBB, and acts as a molecular Trojan horse to ferry the fused IDUA into the brain of patients with MPSI.METHODSThe present investigation describes the initial dosing, plasma pharmacokinetics, and plasma glucose response to the intravenous infusion of doses of valanafusp alpha ranging from 0.3 to 3 mg/kg in five adults and from 1 to 6 mg/kg in 13 pediatric subjects with MPSI.RESULTSValanafusp alpha plasma clearance is increased four-fold in children, and shows a linear pharmacokinetic response over the dose range of 0.3-3 mg/kg with a stable plasma elimination half-life (t_½). The plasma pharmacokinetic parameters for valanafusp alpha overlapped with the same parameters previously reported for recombinant human IDUA (laronidase). The majority of the tested subjects had been receiving laronidase ERT for years, and some showed high levels of anti-drug antibodies (ADAs). However, the presence of these ADAs did not generally alter the rate of plasma clearance of valanafusp alpha in MPSI. The infusion of 0.3-6 mg/kg doses of valanafusp alpha had no effect on plasma glucose for up to 24 h after the drug infusion.CONCLUSIONThe plasma clearance of valanafusp alpha is increased four-fold in children with MPSI compared with adult subjects at a dose of 1-3 mg/kg. The plasma pharmacokinetic profile of valanafusp alpha, at a dose of 1-3 mg/kg, is comparable to that of laronidase in children with MPSI.

2017-12-01·BioDrugs3区 · 医学

Delivery of Biologics Across the Blood–Brain Barrier with Molecular Trojan Horse Technology

3区 · 医学

Review

作者: Pardridge, William M

Biologics are potential new therapeutics for many diseases of the central nervous system. Biologics include recombinant lysosomal enzymes, neurotrophins, decoy receptors, and therapeutic antibodies. These are large molecule drugs that do not cross the blood-brain barrier (BBB). All classes of biologics have been tested, without success, in clinical trials of brain disease over the last 25 years. In none of these past clinical trials was the biologic re-engineered to enable transport across the BBB. If the biologic does not cross the BBB, the drug cannot reach the target site in brain, and success in a clinical trial is not expected. Biologics can be re-engineered for BBB transport with the use of molecular Trojan horse technology. A BBB molecular Trojan horse is a monoclonal antibody (MAb) against an endogenous BBB receptor transporter, such as the insulin receptor or transferrin receptor. The receptor-specific MAb penetrates the brain via transport on the endogenous BBB receptor. The MAb acts as a molecular Trojan horse to deliver across the BBB the biologic pharmaceutical that is genetically fused to the MAb. The lead Trojan horse is a MAb against the human insulin receptor (HIR), and HIRMAb-derived fusion proteins have entered clinical trials for the treatment of brain disease.

项与 ArmaGen, Inc. 相关的新闻（医药）

2023-06-30

·PRNewswire

Proteomics Collaborations: A Comprehensive Review (2010-2023) with Access to Headline, Upfront, Milestone & Royalty Data

DUBLIN, June 30, 2023 /PRNewswire/ -- The "Global Proteomics Partnering Terms and Agreements 2010 to 2023" report has been added to ResearchAndMarkets.com's offering. The Global Proteomics Partnering Terms and Agreements 2010 to 2023 report provides an understanding and access to the proteomics partnering deals and agreements entered into by the world's leading healthcare companies. Trends in proteomics dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to over 600 proteomics deal records and contract documents where available The leading proteomics deals by value since 2010 Most active proteomics dealmakers since 2010 The leading proteomics partnering resources The Global Proteomics Partnering Terms and Agreements report provides an understanding and access to the proteomics partnering deals and agreements entered into by the world's leading healthcare companies. The report provides a detailed understanding and analysis of how and why companies enter proteomics partnering deals. The majority of deals are early development stage whereby the licensee obtains a right or an option right to license the licensors proteomics technology or product candidates. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains links to online copies of actual proteomics deals and contract documents as submitted to the Securities Exchange Commission by companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. For example, analyzing actual company deals and agreements allows assessment of the following: What is actually granted by the agreement to the partner company? What exclusivity is granted? What are the precise rights granted or optioned? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? The initial chapters of this report provide an orientation of proteomics dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in proteomics dealmaking since 2010, including details of average headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading proteomics deals since 2010. Deals are listed by headline value, signed by big pharma, most active proteomics dealmaking companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in proteomics dealmaking with a brief summary followed by a comprehensive listing of proteomics deals, as well as contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand. Chapter 5 provides a comprehensive and detailed review of proteomics partnering deals signed and announced since Jan 2010. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of proteomics partnering deals signed and announced since Jan 2010. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided organized by Proteomics partnering company A-Z, deal type definitions and proteomics partnering agreements example. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The report also includes numerous tables and figures that illustrate the trends and activities in proteomics partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of proteomics technologies and products. Key Topics Covered Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in proteomics dealmaking 2.1. Introduction 2.2. Proteomics partnering over the years 2.3. Most active proteomics dealmakers 2.4. Proteomics partnering by deal type 2.5. Proteomics partnering by therapy area 2.6. Deal terms for proteomics partnering 2.6.1 Proteomics partnering headline values 2.6.2 Proteomics deal upfront payments 2.6.3 Proteomics deal milestone payments 2.6.4 Proteomics royalty rates Chapter 3 - Leading proteomics deals 3.1. Introduction 3.2. Top proteomics deals by value Chapter 4 - Most active proteomics dealmakers 4.1. Introduction 4.2. Most active proteomics dealmakers 4.3. Most active proteomics partnering company profiles Chapter 5 - Proteomics contracts dealmaking directory 5.1. Introduction 5.2. Proteomics contracts dealmaking directory Chapter 6 - Proteomics dealmaking by technology type Appendices Appendix 1 - Proteomics deals by company A-Z Appendix 2 - Proteomics deals by stage of development Appendix 3 - Proteomics deals by deal type Appendix 4 - Proteomics deals by therapy area Deal type definitions Companies Mentioned 3SBio 20/20 BioResponse 21st Century Biochemicals A*STAR Bioinformatics Institute A*STAR Genome Institute of Singapore A*STAR Institute of Microelectronics (IME) AB Analitica Abbvie Abcam Ablynx Abnova Abraxis BioScience Absorption Systems Abt Bio Pharma Solutions Academy for Medical Development & Collaboration Acceleron Pharma Acella Pharmaceuticals ACGT Activiomics ActivX Biosciences ADC Biotechnology Adeona Pharmaceuticals Adimab Aduro BioTech Advaita Advanced Biological Laboratories Advanced BioScience Laboratories Advanced Manufacturing Fund Advinus Therapeutics Aelan Cell Technologies Aestus Therapeutic AEterna Zentaris Affibody Affomix Affymetrix Agilent Technologies AGTC Aileron Therapeutics Ajinomoto AminoScience Alamar Biosciences Albumedix Alexion Pharmaceuticals Allergan Allozyne Almac Diagnostics Almac Group Almirall Alnylam Pharmaceuticals Althea Technologies Altus Pharmaceuticals Alzheimers Research UK Amarantus BioSciences Ambergen Ambrx American College of Cardiology American CryoStem American Health Assistance Foundation Amgen AmorChem Amplimmune Amunix Analytical Testing Laboratory AnaSpec Anchor Therapeutics Angel Biotechnology Anteo Diagnostics Anthera Pharmaceuticals Antigen Discovery Antitope Apeiron Biologics Applied Proteomics Arbor Vita Arbutus Arecor Ariadne Genomics ArmaGen Arrayit Artes Biotechnology Aspera Astellas Pharma AstraZeneca Asuragen ATUM Auburn University Aurigene Discovery Technologies Aushon BioSystems Autism Speaks Autogenesis Auven Therapeutics Avera Heart Hospital of South Dakota Avid Bioservices AvidBiotics Avila Therapeutics Avraham Pharmaceuticals Axil Scientific BaroFold Batavia Biosciences Baxter International Bayer Bayer CropScience Bayer Schering Pharma Baylor College of Medicine BellBrook Labs Bellus Health Berg BGI Americas BG Medicine Bicycle Therapeutics Bill and Melinda Gates Foundation Bio-Techne BioAtla Biocartis Biocius Life Sciences Biocrates Biodesix Bioeasy Diagnostica BioFocus Biogen Biognosys BioGrammatics Biomodels BioNova Cientifica Biopharm BioSante Pharmaceuticals BioSeek Bio Sidus Argentina BioSilta BioSystem Development Biotage Biotechnology and Biological Sciences Research Council (BBSRC) Biotechnology Value Fund Biotest bioVidria BioWa Bioyong BluePen Biomarkers Blue Sky Biotech Boehringer Ingelheim Boehringer Ingelheim Vetmedica BostonGene Bristol-Myers Squibb Bruker Bucher Biotec Bulldog Bio c-LEcta Caladrius Biosciences Caliber Biotherapeutics California Institute for Quantitative Biosciences (QB3) Calixar Cambridge Isotope Laboratories Cambridge Research Biochemicals Camino Partnership Cancer Research Technology Cancer Research UK Cangene Caprion Biosciences Caprion Proteomics Caprotec Bioanalytics For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

2022-12-13

·药时代

干货 | 如何成为一名优秀的BD？

优秀的BD是怎样炼成的？欢迎明天观看直播药时代编者按：LifeSciVC是生物技术界的知名博客，博主是著名的Atlas Venture的投资人Bruce Booth先生。2018年10月9日，该博客发表了美国AVROBIO公司的首席商务官Deanna Petersen女士的文章《Bring Your A-Game for BD》。Deegan女士分享了自己多年从事BD（Business Development，商务拓展）工作的经验、见解。满满的有价值的干货。药时代进行了编译，向朋友们推荐。欢迎朋友们阅读精彩的原文！Deanna Petersen,MBA作者简介：Deanna是一位经验丰富、专业娴熟的高级管理人员，在全球商务拓展和战略规划方面担任领导职位。之前是Shire（夏尔）罕见疾病业务的BD负责人，她和她的团队发现、评估新的商业机会，在5年内谈判并完成了40多项交易（公共并购、私人并购、许可以及其它合作项目），包括以42亿美元收购ViroPharma。在加入夏尔之前，Deanna曾担任Agenus Inc.和Coley Pharmaceutical Group的BD副总裁。Deanna是Tecogen，Inc.（TGEN）的董事会成员，此前曾担任Armagen、美国DG能源公司（ADGE）、马萨诸塞州生物技术协会、医疗保健女企业家协会波士顿分会和波士顿生物制药执行委员会的董事会成员。与大多数职业一样，做好BD工作需要长期的积累。我想从不同的角度分享我多年从事BD工作的一些经验，希望可以帮助从事BD工作的朋友们进一步提升自己的职业生涯，同时，帮助那些目前不从事BD但对这个充满神秘感的职业感兴趣的朋友了解BD的幕后工作。这个领域处于药物开发的许多学科的交叉点，非常活跃。先做一个自我介绍吧。我的BD生涯起步于一所大学的技术转移办公室，然后我转到了一家生物技术初创公司，之后是一家后期开发公司，再然后是一家大型制药公司，就是大家熟知的夏尔。我一步步成长，一个个了解，逐渐熟悉所有这些环境，小公司，大公司，已经做过所有类型的交易，包括许可引进、许可转出、共同开发、战略合作、公共并购、私人并购。打个形象的比喻，谈判桌的东西南北我都坐过。现在，我又回到了一家小公司（我非常热爱这家公司），我今天的大部分分享都是从小公司这个角度出发的，换言之，小公司的BD如何撬动大药企。在深入了解BD技巧之前，请允许我强调拥有一位BD导师的重要性。经验丰富而且乐于传道授业解惑的导师对于一个人建立成功的BD职业生涯非常重要，因为他们可以帮助您快速完善BD所需的各种技能和经验，尽量少走弯路。我的第一个导师，Rose Rennekamp，向我展示了BD的业务和营销策略，特别是识别和定位我的目标对象。她还帮助我从科学思维模式转变为商业思维模式。当我踏入制药行业之时，我遇到了其他指导我如何做交易的导师，包括赛尔公司的前首席企业发展官Barbara Deptula。我有幸与她一起工作，见证了她取得令人印象深刻的成就，帮助夏尔从一家特种药品公司转变为一家有实力的罕见病公司。关于夏尔：1986年，一支仅有数人组成的创业团队推出的治疗方案成功解决了多项亟待得到满足的医疗需求，夏尔由此诞生。在起初两年内，公司推出了一系列用于治疗和预防骨质疏松症的补钙产品。不久之后，公司开始针对具有挑战性的疾病（比如，阿尔茨海默病及终末期肾功能衰竭等）启动了多项创新药物开发项目。至1992年，夏尔已率先开启一系列战略并购——这些大胆的举措不仅巩固了产品线实力，而且还凸显了公司领先的商业模式，即仅专注于向专科医生销售产品。在千禧年到来之后，随着TKT的收购，我们开始关注罕见疾病并持续将该领域列为公司的战略重点。通过创造性的收购举措和创新的产品授权协议，夏尔的产品线得以继续延伸。我们敏锐的商业策略确保了患者的医师能获得必要的信息，并决定适当的治疗方案。2016 年 6 月，夏尔完成与百深的合并，成为专注为罕见病及其他专科疾病患者服务的全球领先生物科技公司。目前，夏尔在全球100 多个国家和地区拥有逾 24,000 名员工，凭借不断扩大的全球影响力和一流的产品，帮助更多患者解决尚未被满足的重大医疗需求。（来源：夏尔中国官网）此外，还有George Golumbeski先生。他曾任Celgene（新基）的BD主管，是我几十年来所熟知的乐于提供建议的领导者。基于丰富的专业知识，Georg为新基公司完成了一些非常创新、富有创造性的大手笔交易。当您开始在BD这条道路上探索前进之际，一定要留意寻找伟大的导师。与此同时，要不断提高自己的技能。这里介绍一些技巧、秘诀。1了解您的目标对象有效的BD开始于有针对性的搜索。好的BD会去发现、研究潜在合作伙伴的战略业务重点和治疗领域。大规模营销不适合生物技术BD。一旦确定目标后，您就可以用下面三个BD技巧建立联系。（1）简洁清晰潜在的BD合作伙伴希望以明确和引人注目的方式将事情简化。从您开始准备初次会议和非保密材料开始，这一点就非常重要。制药公司的朋友在我的职业生涯早期告诉我，“不要让我思考。” 他是一个忙碌的高管，没有大脑空间和时间来快速处理大量的信息、数据，我有责任给他一句精炼抓人眼球的“广告语”，告诉他为什么他应该对我公司的产品感兴趣。当您向前推进BD流程时，保持清晰和有说服力的标准会不断升高。开会时，坐在桌子对面的通常是来自制药公司的几个人，此时您要拿出您最高水平的演讲。呈献一场有说服力的演讲需要时间和思考，以便描绘一个有说服力的故事，让您的观众顺着您的思路，沉浸其中。您可以与内部团队一起微调PPT。需要的话，可以接受外部的专业的培训。另外，请务必安排足够的时间（通常为1.5-2小时）来演讲并回答问题，不要匆忙。匆匆忙忙开会比重新安排以获得足够的时间更糟糕。（2）坚持不懈干BD这一行就要坚持不懈，但绝不当讨厌鬼。两者之间有一条细分的界限。不要担心被拒绝，因为“不”在生物技术中很少是永久性的。我有一句口头禅，“‘不’的寿命只有6个月”，因为生物技术中的每个东西每6个月更换一次。这个有两面性。即使潜在合作伙伴一开始有积极反馈，情况多变，这条路也可能很长而且很曲折。罗马不是一天建成的，BD交易也不是一天搞定的。（3）搞好关系人脉关系是BD的关键之一，这一点是不足为奇的。我有另一种说法，“人们会与他们喜欢的人打交道。” 当合作变得艰难时（会有这样的时期），个人关系可以起到弥补维持的作用。来自大制药公司的朋友告诉我一个关于他们所进行的非常困难的谈判的故事，当时对方给他们造成了许多不必要的不愉快的感受，合同签署了，交易完成了，但是当合作遇到一些困难时，它就很快被终止了。BD朋友说他从未如此高兴很快就终止了一个合作。如果有良好的关系，结局可能就大不相同了。2学会谈判锁定目标对象之后，您的BD工作将向前推进，您需要开始准备条款清单（又称框架协议，term sheet），准备谈判，希望尽快达成合作。在谈判和完成交易方面，这里有3个BD技巧。（1）货比三家我们都知道这句古老的格言“达成交易的最佳方式是拥有多个竞标者。” 这是一个值得努力的目标，因为竞价会促使达成协议。仅仅基于逻辑上、战略上或技术上的契合，很难推动和完成高价值的交易，但如果其他人在竞标，交易价格总是会上涨。从本质上讲，谈判动态会从您与潜在合作伙伴之间的谈判转变为两个（或更多）潜竞标者之间的相互竞争。下面，分享一个真实故事。我曾经与4家大型制药公司洽谈临床I期之前的项目，他们都在我设定的截止日期之前提交了条款清单（给大制药公司设定截止日期，是不是感觉很好呀？~）然后，问题来了。我意识到他们提供的条款清单就像是苹果与橙子，各式各样，很难确定哪个最好。怎么办呢？我将所有对我方最有利的条款和条件合并，准备了一个counter offer，发给所有4家制药公司，并要求他们在截止日期前回复。然后我屏住呼吸，几个晚上都辗转反侧，难以入睡。我开始担心自己是不是我做的有点过分。期限临近，答复开始陆续回来。一家公司坚持他们的第一个条款清单; 两家公司稍微提高了他们的条款清单; 一家公司说：“我们接受你们新的条款清单。” 我松了一口气！后来获胜公司的BD告诉我，他们的管理层知道竞争对手的存在，不想试图节省一点而输给竞争对手。因此，这个技巧奏效了。（2）准备随时抽身而退总是准备好离开谈判桌，否则您将失去主导权。在我的第一份工业界工作中，我们和一家大药企谈判，他们有一位年轻的外聘律师（我们称他为“孩子”），他在每一点上都为公司努力争取，非常努力，但实在令人不舒服，我们决定不再推进谈判。谈了整整一天，到了晚上，我已经受够了，离开了谈判桌，告知对方负责人除非他们将这位“孩子”从他们的团队中请出，否则我们不会再谈判了。想象一下，我必须在第二天的早上向我们小公司的CEO汇报，要解释这一点，这正是交易的重要内容受到细枝末节的影响。令人欣慰的是，大公司的CEO第二天打电话给我们CEO，重申他们有兴趣完成这笔交易。他们谈判负责人问我这位年轻的律师是否可以旁听而不发言，我同意了。双方回到谈判桌，继续进行富有成效的谈判，并完成了交易。（3）知彼知己，百战不殆现在分享一下大型制药公司的BD流程，目的是了解谈判对手，知彼知己百战不殆。制药公司里，BD和技术团队向公司管理团队汇报合作、许可、收购方面的项目进展，如果有必要，也要向董事会汇报。所以，当他们与您谈判的时候，他们已经把自己与该项目联系起来。在获得管理层的批准后，BD团队需要或者完成这笔交易，或向CEO及高级管理层解释他们为何无法实现既定目标。所以，这个阶段的您可能比您想象的还要有力量。3建立人脉关系网人脉关系网就是BD的一切。为此，您将花费大量时间在路上，活跃在生态圈中。这里有一些关于交际的实用技巧。在胸部高高地佩戴您的胸卡，这样任何与您握手的人都可以轻松地看清您的名字。避免使用吊带，它们经常扭来扭去，导致人们看不清或根本看不到您的姓名。提前索要与会者名单，以便了解谁来参加。然后，活动期间精准地寻找目标。在社交招待会上，只在餐巾纸或餐盘上装一点食物，这样如果您发现自己正在进行的谈话不会有收获时，您可以有借口离开，而不要让对方感到尴尬。管理好您的名片册。您将在BD职业生涯中每天使用名片。那么，如何打入BD圈呢？人们经常问我他们如何打入BD圈并得到一份BD工作。以下是一些建议。构建核心BD技能最好的BD专业人士拥有3个领域的专业知识：科学/技术：不需要成为会议室里的专家，但需要能够与科学交流，并回答有关科学的问题。商业/金融：需要能够评估价值和商业潜力。法律：需要了解内部和外部的知识产权（专利和技术诀窍），因为它是大多数交易的核心。根据背景，大多数人都有这3个领域中的2个领域的经验，只有一些人具有所有专业知识。您可以做的是在需要的时候提升您需要的技能。有很多方法可以帮助您。以下是我多年来所做的：科学/技术：我开始为一家免疫肿瘤学公司工作时，我阅读了两本免疫学教科书（是的，我真的读了！），并在哈佛大学攻读了两门免疫学课程。商业/金融：我获得了MBA学位，然后自愿为我的第一家初创公司（Coley Pharmaceutical Group）编写初步商业计划。此外，还参加了评估研讨会、为期一周的MBA课程、并购课程、谈判课程（先举这些例子。）我参加过的最有趣的课程之一就是女性如何进行谈判。法律：我了解了专利和其它形式的知识产权（我在职业生涯早期就学习两门法律课程）。如今，您可以加入LES（Licensing Executives Society）协会并参加他们举办的为期一周的知识产权课程和授权课程。获得相关经验如果您还没有任何直接的BD体验，那么如何获得BD工作呢？这是一个常见的问题。以下是我的一些建议：加入BD（或提供BD课程）专业组织，如许可执行协会（LES）、AUTM（大学管理者协会）、BIO（生物技术产业组织）、MassBio、BioPharma执行委员会（波士顿）等。您还可以参加这些组织的会议和职业发展培训课程。主动帮助自己公司的BD团队。如果贵公司有一个BD团队，请致电主管并自愿帮助他们所需要的任何东西，比如技术评估、业务评估、领域总结、竞争格局摘要、深入分析，等等。这样，BD团队可以了解您和您的技能，您也可以开始了解BD流程。下次他们有一份工作机会，您可能会发现自己处于有利的位置去申请。董事会经验很有帮助，尽早获得董事会经验。您可以从志愿参与非营利组织或慈善事业开始。我一开始在我孩子们的小学里自愿参加学校董事基金会，为新的游乐场设备筹集资金。然后，我自愿为州长做一些经济发展工作。接下，我被邀请加入爱荷华州生物技术协会董事会。当我的孩子从高中毕业时，我有了更多的时间，因此我自愿成为波士顿医疗保健女企业家协会的董事会成员。从那里，我被邀请加入马萨诸塞州生物技术协会董事会，并从那里转到私人生物技术公司（Armagen Technologies）和美国公共能源公司（美国DG Energy，Tecogen，Inc。）董事会。这是一个循序渐进的过程，可以在整个职业生涯中逐步建立起来。4小结BD通常被视为每个人都希望从事的“性感的”工作之一。毕竟，我们总是热衷于看到宣布重大交易的新闻稿，尤其对其中的交易条款感兴趣。像我们这些从事BD职业的人都知道幕后工作有多少。每次交易实际完成都是一个小小的奇迹。希望以上的分享可以帮助朋友们了解这个职业，帮助您进一步打造BD职业生涯，启动并完成一个个新的BD交易。参考资料：Biotech Climate Change（Ros Deegan, CBO of Bicycle Therapeutics，2018-10-01）AVROBIO公司官网夏尔中国公司官网一个广告今年来，生物科技寒冬逐渐传来，资本市场上的资金总量减少，让诸多biotech公司感到了生存压力。但资本市场的冷淡，恰恰是BD交易活跃的时候，毕竟失之股市，收之pharma。今年中国药企license out成功案例频现，天演、多禧、科伦、百奥赛图、和铂......都收获不少。康方和吉利德一周内接连成交数十亿美元的单品交易更是为BD市场添了一把火。但BD交易种类繁多，面对不熟悉的领域，如何正确评估其价值是令每一个BDer头疼的问题。为了帮助广大致力于BD工作或对此职业感兴趣的朋友们系统学习专业知识，掌握最新技能，药时代决定举办创新药BD高阶研讨会，邀请资深专家演讲，分享他们的行业洞见和丰富宝贵的实战经验。点击图片，了解详情！历史上，总金额达到50亿美元的「非并购」BD交易只有9起！其中4个发生在今年...肖恩大侠 | 医药研发中的License In/Out怎么去谈？（附：20篇BD干货文章）一个7.5亿元的BD教训！值得每一位BD人借鉴药时代BD项目药时代BD-021项目 | 国外癌症疫苗公司寻求国内授权或合作研发药时代BD-009项目 | 具有独特MOA且安全、有效的美国IIb期NASH项目寻求中国权益转让药时代BD直播间第1期 | CDMO企业带产品出售药时代BD-007项目 | 潜在FIC KRas靶向的TCR项目寻求合作，转让国内/全球权益药时代BD-012项目 | 高亲和力、高效能CD24靶向单克隆抗体药时代BD-001项目 | 潜在更优THR-β激动剂，目标适应症：NASH和血脂异常。寻找全球或中国权益合作伙伴药时代BD-002项目 | 肿瘤领域潜在FIC项目寻找全球权益合作药时代BD-004项目 | 高效、高选择性，靶向CXCR4口服小分子拮抗剂转让国外权益药时代BD-029-001项目 | BIC潜质HER2/HER2双靶点抗体药时代BD-044项目 | 第三代linker技术ADC新药靶向Claudin18.2 海外公药时代BD高阶研讨会火热报名中！

并购高管变更

2022-06-15

·PRNewswire

Global Orphan Diseases Partnering Deals Report 2022: Access to Headline, Upfront, Milestone and Royalty Data

DUBLIN, June 15, 2022 /PRNewswire/ -- The "Global Orphan Diseases Partnering 2010-2022: Deal Trends, Players and Financials" report has been added to ResearchAndMarkets.com's offering. The Global Orphan Diseases Partnering 2010-2022 report provides comprehensive access to available deals and contract documents for over 280 orphan diseases deals signed between the world's pharmaceutical and biotechnology companies since 2010. Trends in Orphan Diseases partnering deals Financial deal terms for headline, upfront and royalty by stage of development Orphan Diseases partnering agreement structure Orphan Diseases partnering contract documents Top Orphan Diseases deals by value Most active Orphan Diseases dealmakers Most of the deals included within the report occur when a licensee obtains a right or an option right to license a licensor's product or technology. More often these days these deals tend to be multi-component including both a collaborative R&D and a commercialization of outcomes element. The report takes readers through the comprehensive Orphan Diseases disease deal trends, key players and top deal values allowing the understanding of how, why and under what terms companies are currently entering Orphan Diseases deals. The report presents financial deal terms values for Orphan Diseases deals, where available listing by overall headline values, upfront payments, milestones and royalties enabling readers to analyse and benchmark the value of current deals. The initial chapters of this report provide an orientation of Orphan Diseases dealmaking trends. Chapter 2 provides an overview of the trends in Orphan Diseases dealmaking since 2010 covering trends by year, deal type, stage of development, technology type and therapeutic indication. Chapter 3 includes an analysis of financial deal terms covering headline value, upfront payment, milestone payments and royalty rates. Chapter 4 provides a review of the leading Orphan Diseases deals since 2010. Deals are listed by headline value. The chapter includes the top 25 most active Orphan Diseases dealmakers, together with a full listing of deals to which they are a party. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 5 provides comprehensive access to Orphan Diseases deals since 2010 where a deal contract is available, providing the user with direct access to contracts as filed with the SEC regulatory authorities. Each deal title links via Weblink to an online version of the deal record contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive directory of all Orphan Diseases partnering deals by specific Orphan Diseases target announced since 2010. The chapter is organized by specific Orphan Diseases therapeutic target. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided with each report of all Orphan Diseases partnering deals signed and announced since 2010. The appendices are organized by company A-Z, stage of development at signing, deal type (collaborative R&D, co-promotion, licensing etc) and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The report also includes numerous tables and figures that illustrate the trends and activities in Orphan Diseases partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Orphan Diseases technologies and products. Report scope Global Orphan Diseases Partnering 2010 to 2022 includes: Trends in Orphan Diseases dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to hundreds of Orphan Diseases deal contract documents Comprehensive access to over 280 Orphan Diseases deal records The leading Orphan Diseases deals by value since 2010 Most active Orphan Diseases dealmakers since 2010 In Global Orphan Diseases Partnering 2010 to 2022, available deals and contracts are listed by: Headline value Upfront payment value Royalty rate value Stage of development at signing Deal component type Technology type Specific therapy indication Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in Orphan Diseases dealmaking 2.1. Introduction 2.2. Orphan Diseases partnering over the years 2.3. Orphan Diseases partnering by deal type 2.4. Orphan Diseases partnering by industry sector 2.5. Orphan Diseases partnering by stage of development 2.6. Orphan Diseases partnering by technology type Chapter 3 -Financial deal terms for Orphan Diseases partnering 3.1. Introduction 3.2. Disclosed financials terms for Orphan Diseases partnering 3.3. Orphan Diseases partnering headline values 3.4. Orphan Diseases deal upfront payments 3.5. Orphan Diseases deal milestone payments 3.6. Orphan Diseases royalty rates Chapter 4 - Leading Orphan Diseases deals and dealmakers 4.1. Introduction 4.2. Most active in Orphan Diseases partnering 4.3. List of most active dealmakers in Orphan Diseases 4.4. Top Orphan Diseases deals by value Chapter 5 - Orphan Diseases contract document directory 5.1. Introduction 5.2. Orphan Diseases partnering deals where contract document available Chapter 6 - Orphan Diseases dealmaking by therapeutic target 6.1. Introduction 6.2. Deals by Orphan Diseases therapeutic target Appendices Appendix 1 - Directory of Orphan Diseases deals by company A-Z since 2010 Appendix 2 - Directory of Orphan Diseases deals by deal type since 2010 Appendix 3 - Directory of Orphan Diseases deals by stage of development since 2010 Appendix 4 - Directory of Orphan Diseases deals by technology type since 2010 Table of figures Figure 1: Orphan Diseases partnering since 2010 Figure 2: Orphan Diseases partnering by deal type since 2010 Figure 3: Orphan Diseases partnering by industry sector since 2010 Figure 4: Orphan Diseases partnering by stage of development since 2010 Figure 5: Orphan Diseases partnering by technology type since 2010 Figure 6: Orphan Diseases partnering by indication since 2010 Figure 7: Orphan Diseases deals with a headline value Figure 8: Orphan Diseases deals with upfront payment values Figure 9: Orphan Diseases deals with milestone payment Figure 10: Orphan Diseases deals with royalty rates Figure 11: Active Orphan Diseases dealmaking activity since 2010 Figure 12: Top Orphan Diseases deals by value since 2010 Companies Mentioned MSD Action Foundation (MSDAF) Oxford BioMedica Edmond Pharma Ligand Pharmaceuticals Florida Biologix Abbvie Castle Creek Pharmaceuticals Nestle Health Science Enable Injections BioTie Therapies European Commission G-treeBNT OncoSec Medical BioNTech Hematech DBV Technologies Videregen CSL Behring BioXcel Vericel Leukaemia & Lymphoma Research ArmaGen Abiogen Pharma Janssen Sciences Soligenix Medicenna Therapeutics Catalent Cutaneous Lymphoma Foundation Novasep OncoPep Moulder Center for Drug Discovery Research Spooner Girls Foundation Jupiter Orphan Therapeutics Marnier-Lapostolle Foundation Plexcera ProThera Kalytera Therapeutics Acceleron Pharma Regenerx Fortress Biotech Synageva BioPharma ImmuneWorks Rare Expertise For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets

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