Since its inception, ABD Life Sciences has had a consistent record of accomplishment on behalf of its clients. Below you will find some examples of our work.
If your need seems similar to something you see here, please contact us to learn more how we can assist and support you.
Business Development, global assessment of bioreactor & fermenter markets, projects and regulatory implications for a US HQ PE-company.
Business intelligence for a MNC Pharma in the Japanese market. Mapping of public affairs stake holders in Advanced Therapies (Regenerative Medicine, CAR-T, etc.) space and conducting face-to-face interviews in Japan, resulting in a local public affairs plan as a part of a plan for EU, US & Japan. Worked together in a team of global consultants based in EU and US.
Global business development concerning bioprocessing, including COGS, outsourcing and procurement. Together with Mr Bo Forsberg, Forsberg Bio, previously at CMC Biologics.
Business Development in China and Japan for a Phase II asset in CVD and Hospital Care.
The work in Japan was carried out together with Aurora Partners.
Business development focusing on Japan and "greater" China establishing distribution net-work, marketing and sales of antibodies against human proteins for reagent use. Products are based on results from the Human Proteom Atlas (HPA) project at KTH and Uppsala University.
Business and Market Development across Asia for downstream bioprocess product portfolio, including assessing and negotiating distribution agreements, networking with potential customers and partners.
Business Development in Europe, networking and C-level connections with potential customers in drug development or Med. Tech. development.
Business Development in ASEAN, "greater" China, Japan and Korea, support with Regulatory Affairs and Clinical Trials in ASEAN and "greater" China.
In February 2014 a licensing and development agreement was struck between Dilafor and Lee's Pharma (with HQ in Hong Kong). ABD Life Sciences advised Dilafor locally throughout the deal-making process. For the press release see (http://www.dilafor.com).
Some of the regulatory work has been done together with Dr Li Barber, Sr Advisor China Business Development & Regulatory Affairs as well as Prof E K Lee in South Korea.
Project coordination between engineering & construction partner GCEM and FAO in East Timor to design, construct, build, ship and establish a fully functional modular BSL-2 veterinary laboratory (WHO-standard) for Avian Flu monitoring in Dili. This was a first of its kind for Food & Agriculture Organization of the UN (FAO). Conducted together with South Korean engineering partner GCEM.
Sales support, sales channels and distribution in China, South Korea, Japan and Singapore, first period for transfection reagents targeting hard to transfect cell lines, stem cells, primary cells, etc., and in the second period for antibody characterisation reagents.
Work together with Prof. Eun Kyu Lee for the South Korean market.
Business development with the aim of entering the market of selected Southeast Asian countries for molecular diagnostic products and services. Primarily NAT of HPV, but also HBV, and STDs.
Business development and deal-making in China and Japan out-licensing of an ELISA-based diagnostic technology to select responders to IFN-treatment in chronic HBV-patients.
HBV Theranostica is one of Karolinska Development's earlier investments.
Business development putting together a business plan for an international bioprocessing training center at the institute together with Dr Ken Yeung, team leader for the Bioprocessing and Quality groups. Business development advisor during 2007 and 2008.
GMP gap-analysis (PIC/S) for advanced therapies (regenerative medicine) of pilot stem cell manufacturing facility in Hong Kong, at Li Ka Shing Institute for Health Science, Prince of Wales Hospital, Chinese Univeristy, together with Mr Magnus Jahnsson now at Pharmadule Morimatsu (2011).
Market Assessment in China, including KOL & Patient Interviews, for a dermatology Phase II asset.
The work was carried out together with B-Core Consulting in Beijing.
Business Development and partnering in Europe for in-licensing of a platform technology and possible co-development of a therapy for muscular atrophies including Duchenne muscular dystrophy and polymyositis.
Business Development, strategy and business intelligence paving the way for the establishment of a new business unit in life science focusing on analysis of biological samples and in vitro diagnostics.
The work was conducted together with Aurora Partners in Japan and Reomics in Sweden.
Supporting Karolinska Development and several of its portfolio companies (Aprea, Athera, BioSergen, Dilafor, HBV Theranostica, Pharmanest, Pergamum, etc.) in Asia in business development, establishing contacts, net-working, deal support, business intelligence, due diligence, etc.
Karolinska Development is a Stockholm-based seed financing, investment and management company bringing carefully selected and nurtured academic innovations to commercilization. From more than 1.500 reviewed innovations and over 60 start-up companies created have brought a large number of projects into clinical trials phase I, II and POC in man.
ABD Life Sciences' work has been focused on targeting leading pharma companies in China, Japan and South Korea for out-licensing of drug candidates in pre-clinical, Phase I or II. This involved arranging road-shows in Japan 2009, 2010 and 2011, as well as attending various conferences and meetings in China, Japan and South Korea 2010 - 2013.
Business Development work in China to establish KLIFO, a Danish Drug Development Consulting Company with regulatory affairs, clinical trial (Phase I-IV), clinical trial supply and drug development consulting services, as an enabler for Chinese companies to get their generic, pharmaceutical, biologic, biosimilar and/or med tech products approvable and ultimately approved and reimbursed in the various markets in EU. The initial work during 2013-2014 was together with Dr Steve Porter, Dragon Bio-consultants, while Mr. Bill Porter has continued to provide administrative support during 2015. ABD has also been working together in China with both foreign and local engineering, regulatory and clinical research companies. The first deal was signed in 2014.
In 2015 similar business development work has been initiated in Japan, where ABD works together with Mr. Johan Westblad, founder of Aurora Partners KK, http://www.aurorapartners.jp.
On site GMP-audit of insulin and insulin analogue production site in accordance with PIC/S, EMA and USFDA GMPs.
This work was done together with Magnus Jahnsson at Pharmadule Morimatsu.
GMP gap-analysis, advice and support in developing Validation Master Plan (VMP), IQ/OQ procedures, Receipt Verification (RV), SOPs, URS, etc. meetings PIC/S, CFDA, HKDH, EMA and USFDA GMPs as well as at least BSL-2 complaince.
This work was done together with Magnus Jahnsson and his team at Pharmadule Morimatsu.
Business Development and cross-cultural communications in China.
Price & Reimbursement in China and CFDA Regulatory Affairs review together with Li Barber.
Regulatory and Business Development support in South Korea & China.
Consulting.
Global Business Development, but first in 2010 only focusing on Japan , then in 2011 China and Korea, from 2012 globally.
Oncopeptides is developing a peptidase potentiated therapy, melflufen, currently in clinical development in relapsed and relapsed refractory multiple myeloma. The clinical trials are conducted at seven sites in Europe and US. This potential First-in-Class therapy is supported by Health Cap and Industrifonden as lead investors and more than EUR16.5 has so far been raised. Karolinska Development was an earlier investor, but was replaced by Health Cap in 2011.
Business development, marketing & sales support, including bioprocess trouble shooting at customer’s sites in India, China, Taiwan, South Korea and elsewhere in the region, as well as internal bioprocess training across Asia for the biopharma division.
Lecturing in Malaysia (2009).
In-house GMP-training of inspectors and auditors in China together with Ambrose Consulting.
Regulatory advice regarding CFDA and partnering in mainland China.
This work was done together with Dr Li Barber, Sr Advisor China Business Development & Regulatory Affairs
Regulatory advice regarding CFDA and Chinese Ministry of Health regulations as well as Chinese Customs for importation of health and medical products to China.
This work was done together with Dr Li Barber, Sr Advisor China Business Development & Regulatory Affairs
Business Development and Regulatory Affairs in mainland China.
The work was conducted together with Dr Li Barber.
Senior visiting lecturer in the MBI-training program for Bioprocess Engineering designed for M.Sc.- and Ph.D students as well as individuals attending from industry as a part of a post-graduate program. Involved in both in the facility design (discussing modular facilities, containment, stainless steel Vs disposable equipment, QbD, PAT, etc) and downstream processing, focusing on chromatography. including a 4 hour work-shop (mAb purification) together with Mr Bo Forsberg, CMC Biologics. In 2010 developed a new presentation for the vaccine manufacturing facilities together with Kjell Jansson, Projekt Engagemang.
Business Development in China providing comparison of domestic mAb-manufacturers, including on-site audit of one production facility
Performing feasibility studies for possible establishment of CRO & CMO services as well as nanotechnology in the planned Shijir International Science City, Boroo Valley 150km north of Ulaanbataar. Working together with GH-Bioquenta, as well as other specialists in ABD's network.
Feasibility study Japan of a clinical stage oncology asset with market and regulatory assessments.
The work was carried out together with Aurora Partners.