Suzanne ElvidgeOctober 15, 2024
Tag: Outsourcing , Pipelines , Partnering
Working in partnership, whether through collaborations, alliances, in-or out-licensing or outsourcing, or even through mergers and acquisitions, is a powerful way to boost pipelines and support preclinical and clinical research and development. [1] The challenge is finding the right partner and the right product or project, and this may be with the company in the next building, or halfway around the world.
Working with a smaller company can provide access to specialist knowledge and cutting-edge research, whereas working with a bigger company provides access to clinical trials, sales, marketing and manufacturing knowledge and experience. Looking for the right asset or partner means exploring strategic synergies and complementary strengths, and there are a number of avenues to explore, both digital and face-to-face.
Having a target profile of an ideal partner and/or product in mind [2], and thinking about the who, what and why, can help at the beginning of the partnering process. As part of this process, consider the ‘4 Ws’: [3]
· Who are your partners?
· What do they want?
· Why do they want it?
· How do they recognize what they want?
For companies seeking to in-license a product or technology, creating a target product profile (TPP) that brings together the critical aspects of the product sought is a practical start. If kept updated, the TPP can also provide a framework for preclinical and clinical development and streamline interactions with regulatory authorities. Suggested attributes to use in the TPP include: [4]
· Patient population
· Primary endpoints
· Interference
· Safety and tolerability
· Dosing
· Dosage regimen or schedule
· Stability
· Process-derived impurities
· Patient population
This can be extended into a target licensing profile (TLP), which will also cross over into due diligence (see later). The TLP can include the following additional attributes: [5]
· Therapeutic hypothesis
· Development stage
· Requirement for preclinical or clinical data
· IND-enabling plans or data
· CMC (chemistry, manufacturing and controls) information
· Estimated costs
· Clinical trial plans or data
· IP position
· Commercial analysis
· Current standards of care
· Unmet needs
· Pricing and reimbursement estimates
Selecting the right product and/or partner starts with desk research. Scientific research published in journals, conference reports and abstracts can help to identify emerging opportunities and indicate companies’ recent research. Papers may also list a corresponding author for an initial point of contact. While these may not be the person who can discuss licensing opportunities, they may be able to direct enquiries.
Company’s websites and annual reports describe their areas of focus and will often give details of their pipelines, particularly the assets that are in clinical trials. They may also have a business development or marketing web page, including what they are looking for or offering for collaboration or licensing, along with contact details for the teams involved. [3, 6]
Partnering conferences, whether digital or ‘in real life’, provide opportunities for companies to showcase their available technologies, platforms and assets, through presentations and face-to-face or virtual networking. Partnering conferences can be local, national or international. They can also be across technologies and therapeutic areas or focused on specific indications or approaches. Attendees include C-suite and senior level management as well as individuals at earlier stages or their careers.
Scientific conferences are a good way to keep abreast of cutting-edge science, and to meet key opinion leaders who can offer advice on new areas of research. Serendipitous meetings over coffee or at lunch or dinner can be a way to start useful discussions.
While partnering and scientific conferences provide targeted networking opportunities, networking can also be a more organic process. Fellow students from undergraduate and postgraduate courses and colleagues from previous jobs may turn out to be useful contacts, either directly or as a route to the right people. Networking sites such as LinkedIn provide opportunities for virtual networking across the world. Networking, particularly for smaller companies, should include people outside biotech and pharma R&D, including potential investors and financial, legal technology transfer and business development experts.
Databases provide access to companies and licensing/partnering opportunities across biotech, pharma, medtech, digital health and other life sciences sectors. Databases may be general or targeted to particular areas, such as cell and gene therapies. They can be searched using a variety of parameters, including: [7]
· Type of partnership sought – M&A, in-/out-licensing, collaboration
· Type of partner – big pharma, biotech, start-up, academia
· Therapeutic area
· Drug target
· Mechanism of action
· Type of asset
· Stage of development
· Geographic markets
· Deal activity
· Previous partnerships
· Funding status
Specialist consultants can provide external advice for companies seeking the right product or partner. They bring experience and expertise, often from long careers in biopharma partnering. They may also be able to access hard-to-find information and up-to-date market knowledge, and make introductions to the right people. [3]
Based on thorough research, including insights from networks, market reports, and news sources, due diligence is an important step in licensing and partnering, to ensure that companies select the right partnership or product. Start by ensuring that the internal resources are in place for the due diligence activity, and consider on-site visits. [2]
Things to assess include: [2, 7]
· For assets:
o Do the key rights to the products or technologies belong to the potential partner?
o Is the asset a strategic fit?
o Is the asset at the right development stage to fit into the pipeline?
o Is the patent coverage appropriate and is there a long enough time left on the patent?
o Are the projected costs, internal resources, expertise and capabilities achievable?
o Has the partner provided all the required data and information, and has this been reviewed?
· For partners:
o Does the partnership provide the right practical and/or strategic fit?
o Does the partnership provide access to the wanted markets or therapeutic areas?
o Does the partner have the required experience and expertise?
The route towards a partnership can be long and complex, but putting in the groundwork and making thorough preparations will increase the likelihood of a long-term and successful partnership for both parties.
1. Elvidge, S., Working Collaboratively: Using Co-operation to Boost Pipelines. Pharma Sources: An Eye on the Biopharma Industry, 26 September 2024. Available from: https://www.pharmasources.com/industryinsights/working-collaboratively-using-co-operati-76751.html.
2. Seimetz, D. and J. Schneider, Scientific Due Diligence: The Key to Successful Partnerships. BioPharm International, 9 June 2022. Available from: https://www.biopharminternational.com/view/scientific-due-diligence-the-key-to-successful-partnerships.
3. Sibinovic, M. and E. Adjogatse. How to find partners. Probacure. Last accessed: 7 January 2022.
4. Creating a Target Product Profile for New Drug Products America's Seed Fund. Last accessed: 9 October 2024 2024. Available from: https://seed.nih.gov/sites/default/files/2023-12/Creating-Target-Profile-for-New-Drug-Products.pdf.
5. Southwell, A. and A. Walker. Planning for Pharma Partnering. Alacrita. Last accessed: 9 October 2024. Available from: https://www.alacrita.com/blog/pharma-partnering-success.
6. Tips for Partnering with Big Pharma. University Lab Partners. Last accessed: 19 October 2020. Available from: https://www.universitylabpartners.org/blog/tips-for-partnering-with-big-pharma.
7. The Complete Dealmaking Guide to Out-licensing and Partnering for Pharma and Biotech Companies. Biopharma Vantage. Last accessed: 7 August 2023. Available from: https://www.biopharmavantage.com/guide-out-licensing-pharma-biotech.
Based in the north of England, Suzanne Elvidge is a freelance medical writer with a 30-year experience in journalism, feature writing, publishing, communications and PR. She has written features and news for a range of publications, including BioPharma Dive, Pharmaceutical Journal, Nature Biotechnology, Nature BioPharma Dealmakers, Nature InsideView and other Nature publications, to name just a few. She has also written in-depth reports and ebooks on a range of industry and disease topics for FirstWord, PharmaSources, and FierceMarkets. Suzanne became a freelancer in 2006, and she writes about pharmaceuticals, consumer healthcare and medicine, and the healthcare, pharmaceutical and biotechnology industries, for industry, science, healthcare professional and patient audiences.
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